FDA Product Code
FDA Product Code HWC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 1,069 records · page 5 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K112737 | TIGER HEADLESS CANNULATED SCREWS | Trilliant Surgical, Ltd. | 2011-10-20 | Special | PDF ↗ |
| K111994 | SMITH & NEPHEW CANNULATED SCREWS AND WASHERS | Smith & Nephew, Inc. | 2011-10-11 | Traditional | PDF ↗ |
| K112772 | ORTHOLOC(TM) BONE SCREWS | Wrightmedicaltechnologyinc | 2011-10-07 | Special | PDF ↗ |
| K111447 | ZIMMER PERIARTICULAR SCREWS | Zimmer, Inc. | 2011-10-05 | Traditional | PDF ↗ |
| K112237 | MICROSUTURE ANCHORS | Arthrex, Inc. | 2011-09-02 | Special | PDF ↗ |
| K111608 | SLIC SCREW REPAIR SYSTEM | Acumed, LLC | 2011-08-29 | Special | PDF ↗ |
| K111799 | NUGAIT(TM) SUBTALAR IMPLANT SYSTEM | Ascension Orthopedic | 2011-08-19 | Traditional | PDF ↗ |
| K111265 | METASURG SUBTALAR IMPLANT | Metasurg | 2011-08-09 | Traditional | PDF ↗ |
| K102528 | N-FORCE FIXATION SYSTEM | Innovision, Inc. | 2011-07-28 | Traditional | PDF ↗ |
| K111000 | PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR | Parcus Medical, LLC | 2011-07-28 | Traditional | PDF ↗ |
| K110592 | 3.7MM/5.0MM DYNAMIC LOCKING SCREW | Synthes USA | 2011-07-25 | Traditional | PDF ↗ |
| K111536 | METASURG DIGIFUSE IMPLANT | Metasurg | 2011-07-21 | Traditional | PDF ↗ |
| K111316 | AAP CANNULATED SCREWS | Aap Implantate AG | 2011-07-20 | Special | PDF ↗ |
| K110538 | PRO FIXATION SYSTEM | Synovis Orthopedic & Woundcare | 2011-07-12 | Traditional | PDF ↗ |
| K110658 | APTUS CANNULATED COMPRESSION SCREWS | Medartis AG | 2011-06-02 | Traditional | PDF ↗ |
| K111230 | SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW | Synthes (USA) Products, LLC | 2011-05-24 | Traditional | PDF ↗ |
| K111001 | STERILE STORM (R) OPERATING KIT | Intelligent Orthopaedics, Ltd. | 2011-05-17 | Special | PDF ↗ |
| K102324 | ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM | Wrightmedicaltechnologyinc | 2011-05-04 | Traditional | PDF ↗ |
| K110763 | LATARJET CORTICAL SCREW SET | T.A.G. Medical Products Corporation, Ltd. | 2011-04-11 | Special | PDF ↗ |
| K103705 | LOW PROFILE SCREWS | Arthrex, Inc. | 2011-03-18 | Traditional | PDF ↗ |
| K110445 | FLEXFUSION (TM) FIXATION IMPLANT | Nextremity Solutions, LLC | 2011-03-17 | Traditional | PDF ↗ |
| K103712 | GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD | Depuy Mitek, A Johnson & Johnson Company | 2011-03-11 | Traditional | PDF ↗ |
| K103183 | TRILLIANT SURGICAL SUBTALAR IMPLANT | Trilliant Surgical, Ltd. | 2011-02-08 | Traditional | PDF ↗ |
| K102298 | TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND | Depuy Mitek, A Johnson & Johnson Company | 2011-01-07 | Traditional | PDF ↗ |
| K102410 | MATRYX INTERFERENCE SCREW (5.0-6.5MM) | Conmed Linvatec | 2010-12-21 | Traditional | PDF ↗ |
| K102343 | EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM | Emerge Medical | 2010-11-23 | Traditional | PDF ↗ |
| K100721 | LOCKING BONE SCREW MODEL HCQ04, HCZ04 | Changzhou Orthmar Medical Instrument Co., Ltd. | 2010-11-23 | Traditional | PDF ↗ |
| K093055 | CSTS SCREW | Orthopro, LLC | 2010-11-22 | Traditional | PDF ↗ |
| K102326 | PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR | Parcus Medical, LLC | 2010-11-15 | Traditional | PDF ↗ |
| K102162 | PARCUS PEEK CF PUSH-IN SUTURE ANCHOR | Parcus Medical, LLC | 2010-11-10 | Traditional | PDF ↗ |
| K101808 | SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER | Medshape Solutions | 2010-11-08 | Traditional | PDF ↗ |
| K102903 | PIONEER CANNULATED SCREW SYSTEM | Pioneer Surgical Technology, Inc. | 2010-10-20 | Special | PDF ↗ |
| K101700 | IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM | Extremity Medical, LLC | 2010-10-12 | Traditional | PDF ↗ |
| K101696 | MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM | Zimmer, Inc. | 2010-09-10 | Traditional | PDF ↗ |
| K101165 | PRO-TOE VO HAMMERTOW IMPLANT SYSTEM | Wrightmedicaltechnologyinc | 2010-07-23 | Traditional | PDF ↗ |
| K101254 | NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM | Tecnologia Y Diseno Industrial, S.A DE C.V | 2010-07-15 | Traditional | PDF ↗ |
| K100359 | DARCO HEADED CANNULATED SCREW | Wrightmedicaltechnologyinc | 2010-06-24 | Traditional | PDF ↗ |
| K093078 | UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS | Bonutti Research, Inc. | 2010-06-23 | Special | PDF ↗ |
| K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW | Biopro, Inc. | 2010-06-03 | Special | PDF ↗ |
| K093820 | SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010-05-19 | Traditional | PDF ↗ |
| K100325 | PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES | Smith & Nephew, Inc. | 2010-05-04 | Traditional | PDF ↗ |
| K093770 | EXTREMITY MEDICAL SCREW SYSTEM | Extremity Medical, LLC | 2010-04-28 | Traditional | PDF ↗ |
| K100457 | OPUS SPEEDSCREW SYSTEM | Arthrocare Corp. | 2010-03-19 | Special | PDF ↗ |
| K100532 | VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 | Depuy Mitek, A Johnson & Johnson Company | 2010-03-17 | Special | PDF ↗ |
| K093676 | OMNITECH LARGE, TRIMED COMPRESSION SCREW | TriMed, Inc. | 2010-03-17 | Traditional | PDF ↗ |
| K092754 | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 | Small Bone Innovations, Inc. | 2010-01-19 | Traditional | PDF ↗ |
| K092909 | SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) | Synthes (Usa) | 2010-01-11 | Traditional | PDF ↗ |
| K091118 | FOOT AND HAND MOTION SYSTEM | Newclip Technics | 2009-12-16 | Traditional | PDF ↗ |
| K091686 | LEFORTE NEUROSYSTEM BONE SCREW | Jeil Medical Corporation | 2009-11-13 | Traditional | PDF ↗ |
| K092133 | ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N | Arthrocare Corp. | 2009-11-05 | Traditional | PDF ↗ |
| K092440 | ASCENSION CANNULATED SCREW SYSTEM | Ascension Orthopedics, Inc. | 2009-11-05 | Traditional | PDF ↗ |
| K092082 | SYNERGY CANNULATED SCREW SYSTEM | Synergy Surgical Technologies, LLC | 2009-10-02 | Traditional | PDF ↗ |
| K091093 | PARCUS PPEK CF INTERFERENCE SCREW | Parcus Medical, LLC | 2009-09-30 | Traditional | PDF ↗ |
| K092189 | POGO SCREW | Fxdevices | 2009-09-18 | Special | PDF ↗ |
| K091202 | WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, | Medshape Solutions | 2009-09-16 | Traditional | PDF ↗ |
| K090175 | UNITY BETA PLLA SYSTEM | Bonutti Research, Inc. | 2009-09-10 | Traditional | PDF ↗ |
| K091798 | MERETE COMPRESSION SCREWS | Merete Medical GmbH | 2009-09-02 | Traditional | PDF ↗ |
| K090949 | SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS | Synthes (Usa) | 2009-07-31 | Traditional | PDF ↗ |
| K091577 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM | Extremity Medical, LLC | 2009-07-24 | Traditional | PDF ↗ |
| K083912 | TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS | Treu-Instrumente GmbH | 2009-07-15 | Traditional | PDF ↗ |
| K091694 | MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) | Tag Medical Products | 2009-07-07 | Special | PDF ↗ |
| K090656 | INTERTAN CHS LIMITED COLLAPSE SET SCREW | Smith & Nephew, Inc. | 2009-06-03 | Traditional | PDF ↗ |
| K091069 | MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT | Medacta International S.A. | 2009-06-01 | Traditional | PDF ↗ |
| K081122 | FUSION MEDICAL CANNULATED SCREW SYSTEM | John Riccio | 2009-05-26 | Traditional | PDF ↗ |
| K081755 | FUSION MEDICAL STI | John Riccio | 2009-05-20 | Traditional | PDF ↗ |
| K090994 | LIGAFIX INTERFACE SCREW | Science For Biomaterials | 2009-05-06 | Special | PDF ↗ |
| K082934 | EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM | Extremity Medical, LLC | 2009-04-23 | Traditional | PDF ↗ |
| K083096 | LATARJET CORTICAL SCREW SET | Tag Medical Products | 2009-04-17 | Traditional | PDF ↗ |
| K083792 | WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 | Medshape Solutions | 2009-03-25 | Traditional | PDF ↗ |
| K081813 | UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM | U.S. Implant Solutions, LLC | 2009-03-12 | Traditional | PDF ↗ |
| K083619 | PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 | Parcus Medical, LLC | 2009-03-06 | Traditional | PDF ↗ |
| K083612 | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM | Cayenne Medical, Inc. | 2009-03-04 | Traditional | PDF ↗ |
| K083607 | APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM | Cayenne Medical, Inc. | 2009-03-04 | Traditional | PDF ↗ |
| K082874 | BIODRIVE CANNULATED SCREW SYSTEM | Biomet Trauma | 2009-02-05 | Traditional | PDF ↗ |
| K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM | Orthohelix Surgical Designs, Inc. | 2008-12-08 | Special | PDF ↗ |
| K080649 | POGO SCREW | Fxdevices | 2008-11-25 | Traditional | PDF ↗ |
| K082949 | ORTHOPEDIATRICS BONE SCREWS | OrthoPediatrics Corp. | 2008-11-25 | Traditional | PDF ↗ |
| K082282 | HEALIX TI ANCHOR | Depuy Mitek, A Johnson & Johnson Co. | 2008-11-07 | Traditional | PDF ↗ |
| K081011 | AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 | Arex USA | 2008-11-07 | Traditional | PDF ↗ |
| K082320 | DARCO SMALL SCREW | Wrightmedicaltechnologyinc | 2008-11-05 | Traditional | PDF ↗ |
| K082906 | UNITY BETA ANCHOR SYSTEM | Bonutti Research, Inc. | 2008-10-30 | Special | PDF ↗ |
| K081893 | OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 | Arthrocare Corp. | 2008-10-01 | Traditional | PDF ↗ |
| K082516 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS | Smith & Nephew, Inc. | 2008-09-17 | Special | PDF ↗ |
| K081934 | EXTREMITY MEDICAL COMPRESSION SCREW | Extremity Medical, LLC | 2008-08-29 | Traditional | PDF ↗ |
| K080259 | JMEA CANNULATED BONE SCREW SYSTEM | Jmea Corporation | 2008-08-20 | Traditional | PDF ↗ |
| K081390 | BIOACTIF OSTEOTRANS INTERFENCE SCREW | Takiron Co., Ltd. | 2008-08-12 | Traditional | PDF ↗ |
| K081149 | BIOPRO GO-EZ SCREW | Biopro, Inc. | 2008-08-05 | Traditional | PDF ↗ |
| K081510 | TIGER CANNULATED SCREW SYSTEM | Trilliant Surgical, Ltd. | 2008-08-04 | Traditional | PDF ↗ |
| K073159 | TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2008-07-23 | Traditional | PDF ↗ |
| K081513 | MERETE 3.0 AND 3.5 MM LOCKING SCREWS | Merete Medical GmbH | 2008-07-18 | Traditional | PDF ↗ |
| K081700 | SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION | Synthes (Usa) | 2008-07-17 | Special | PDF ↗ |
| K072291 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR | Conmed Linvatec | 2008-07-14 | Traditional | PDF ↗ |
| K080778 | ENSPLINT TM BONE SCREW | Sonoma Orthopedic Products, Inc. | 2008-07-10 | Traditional | PDF ↗ |
| K080974 | TLS FIXATION SYSTEM | Fournitures Hospitalieres Industrie | 2008-07-01 | Traditional | PDF ↗ |
| K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | Biocomposites, Ltd. | 2008-06-20 | Special | PDF ↗ |
| K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN | Bioretec, Ltd. | 2008-06-18 | Special | PDF ↗ |
| K080088 | BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS | Biomet Manufacturing, Inc. | 2008-06-11 | Traditional | PDF ↗ |
| K073312 | OSTEOTRANS-OT SCREW | Takiron Co., Ltd. | 2008-05-13 | Traditional | PDF ↗ |
| K081071 | SYNTHES 6.5MM MIDFOOT FUSION BOLT | Synthes (Usa) | 2008-05-01 | Traditional | PDF ↗ |
| K080943 | SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS | Synthes (Usa) | 2008-04-23 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.