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 6 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K080943 | SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS | Synthes (Usa) | 2008-04-23 | Traditional | PDF ↗ |
| K080850 | DARCO HEADLESS COMPRESSION SCREW | Wrightmedicaltechnologyinc | 2008-04-10 | Special | PDF ↗ |
| K080101 | AAP CANNULATED SCREW AND DARCO HEADED SCREW | Aap Implantate AG | 2008-03-25 | Special | PDF ↗ |
| K080280 | SUB-TALAR LOK, MODEL 7-11 MM | Instratek, Inc. | 2008-03-14 | Traditional | PDF ↗ |
| K080352 | MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE | Depuy Mitek, A Johnson & Johnson Company | 2008-03-12 | Special | PDF ↗ |
| K073509 | TWINFIX PK FP SUTURE ANCHOR | Smith & Nephew, Inc. | 2008-03-04 | Traditional | PDF ↗ |
| K073426 | APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM | Cayenne Medical, Inc. | 2008-02-19 | Traditional | PDF ↗ |
| K072785 | TWINFIX FT PK | Smith & Nephew Inc., Endoscopy Division | 2007-12-10 | Traditional | PDF ↗ |
| K071941 | MEMOMETAL BONE ANCHORS | Memometal Technologies | 2007-12-04 | Traditional | PDF ↗ |
| K073054 | MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER | Cayenne Medical, Inc. | 2007-11-27 | Special | PDF ↗ |
| K072848 | ACTIVASCREW | Bioretec, Ltd. | 2007-11-02 | Special | PDF ↗ |
| K071816 | HARPOON SUTURE ANCHOR | Biomet Sports Medicine, Inc. | 2007-09-20 | Traditional | PDF ↗ |
| K071157 | STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS | Stryker Endoscopy | 2007-09-17 | Traditional | PDF ↗ |
| K071437 | MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C | KARL STORZ Endoscopy-America, Inc. | 2007-09-12 | Traditional | PDF ↗ |
| K071541 | SBI TWISTOFIX | Small Bone Innovations, Inc. | 2007-09-10 | Traditional | PDF ↗ |
| K072127 | DOMINATOR | Biocomposites, Ltd. | 2007-08-31 | Special | PDF ↗ |
| K063635 | SBI FOREFOOT SET | Small Bone Innovations, Inc. | 2007-08-29 | Traditional | PDF ↗ |
| K071656 | SBI ARTFIX | Small Bone Innovations, Inc. | 2007-08-27 | Traditional | PDF ↗ |
| K071952 | GRAFTLOCK SCREW, ST SCREW | Biocomposites, Ltd. | 2007-08-14 | Special | PDF ↗ |
| K071035 | IFS BONE FIXATION DEVICES | Internal Fixation Systems, Inc. | 2007-08-13 | Traditional | PDF ↗ |
| K071481 | HEALIX ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2007-08-09 | Traditional | PDF ↗ |
| K070389 | PEEK KNOTLESS ANCHORS | Biomet Sports Medicine, Inc. | 2007-08-09 | Traditional | PDF ↗ |
| K071464 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | Inion OY | 2007-08-03 | Traditional | PDF ↗ |
| K071498 | SUBTALAR IMPLANT | Biomet Sports Medicine, Inc. | 2007-07-31 | Traditional | PDF ↗ |
| K071639 | QWIX POSITIONING SCREW | Newdeal Sas | 2007-07-09 | Special | PDF ↗ |
| K071177 | ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW | Arthrex, Inc. | 2007-06-29 | Special | PDF ↗ |
| K070617 | CANNULATED SCREW | Fournitures Hospitalieres Industrie | 2007-06-14 | Traditional | PDF ↗ |
| K071115 | MODIFICATION TO BILOK ST SCREW | Biocomposites, Ltd. | 2007-05-17 | Special | PDF ↗ |
| K071091 | MODIFICATION TO BILOK SCREW | Biocomposites, Ltd. | 2007-05-17 | Special | PDF ↗ |
| K071092 | ASNIS MICRO CANNULATED SCREW | Howmedica Osteonics Corp. | 2007-05-11 | Special | PDF ↗ |
| K070347 | ALLOFIX PUSH-IN ANCHOR | Musculoskeletal Transplant Foundation | 2007-05-11 | Traditional | PDF ↗ |
| K063584 | STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 | Regeneration Technologies, Inc. | 2007-05-09 | Traditional | PDF ↗ |
| K070441 | METASURG SUBTALAR IMPLANT | Metasurg | 2007-05-08 | Traditional | PDF ↗ |
| K070393 | LAGWIRE SYSTEM | Fxdevices | 2007-05-04 | Traditional | PDF ↗ |
| K070906 | MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS | Zimmer, Inc. | 2007-05-01 | Special | PDF ↗ |
| K070525 | CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER | Wrightmedicaltechnologyinc | 2007-03-29 | Special | PDF ↗ |
| K070507 | MODIFICATION TO: LIGAFIX INTERFERENCE SCREW | Science For Biomaterials | 2007-03-29 | Special | PDF ↗ |
| K070039 | MEMOMETAL FIXOS SCREWS | Memometal Technologies | 2007-03-21 | Traditional | PDF ↗ |
| K062820 | UNITY ALPHA SYSTEM | Bonutti Research, Inc. | 2007-03-15 | Traditional | PDF ↗ |
| K063298 | OSTEOMED HEADLESS CANNULATED SCREW SYSTEM | Osteomed LP | 2007-03-02 | Traditional | PDF ↗ |
| K063588 | MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 | Conmed Linvatec Biomaterials | 2007-03-02 | Traditional | PDF ↗ |
| K063589 | GSO BONE FIXATION FASTENERS | Gold Standard Orthopaedics, LLC | 2007-01-31 | Traditional | PDF ↗ |
| K063244 | ARC SURGICAL BONE REDUCTION SCREW | Arc Surgical, LLC | 2006-12-27 | Traditional | PDF ↗ |
| K063478 | VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) | Depuy Mitek, A Johnson & Johnson Company | 2006-12-15 | Special | PDF ↗ |
| K063070 | APERFIX TIBIAL IMPLANT WITH INSERTER | Cayenne Medical, Inc. | 2006-12-14 | Traditional | PDF ↗ |
| K063479 | ARTHREX PUSHLOCK | Arthrex, Inc. | 2006-12-13 | Special | PDF ↗ |
| K062980 | ACTIVASCREW | Bioretec, Ltd. | 2006-11-22 | Traditional | PDF ↗ |
| K062487 | APERFIX FEMORAL IMPLANT WITH INSERTER | Cayenne Medical, Inc. | 2006-11-17 | Traditional | PDF ↗ |
| K062863 | OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM | Osteomed LP | 2006-10-31 | Traditional | PDF ↗ |
| K062103 | DARCO FORCE TITANIUM COMPRESSION SCREW | Darco International, Inc. | 2006-10-25 | Traditional | PDF ↗ |
| K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY | Arthrex, Inc. | 2006-10-19 | Traditional | PDF ↗ |
| K062352 | FRS SCREW | DePuy Orthopaedics, Inc. | 2006-10-19 | Traditional | PDF ↗ |
| K062617 | MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM | Inion , Ltd. | 2006-10-04 | Special | PDF ↗ |
| K062679 | ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES | Arthrex, Inc. | 2006-09-27 | Special | PDF ↗ |
| K061949 | DOUBLEPLAY SUTURE ANCHOR | Biocomposites, Ltd. | 2006-09-25 | Traditional | PDF ↗ |
| K061763 | ARC SURGICAL BIOTRAK SCREW | Arc Surgical, LLC | 2006-09-19 | Traditional | PDF ↗ |
| K062348 | TIMESH SELF DRILLING SCREW | Medtronic Neurosurgery | 2006-09-08 | Special | PDF ↗ |
| K061621 | SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS | Synthes (Usa) | 2006-07-27 | Traditional | PDF ↗ |
| K061620 | IFS CANNULATED BONE SCREW | Internal Fixation Systems, Inc. | 2006-07-26 | Traditional | PDF ↗ |
| K061665 | ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT | Arthrex, Inc. | 2006-07-25 | Special | PDF ↗ |
| K061765 | KALIX II IMPLANT | New Deal, S.A. | 2006-07-18 | Special | PDF ↗ |
| K061262 | LIGAFIX INTERFERENCE SCREW | Sciences For Bio Materials | 2006-07-05 | Special | PDF ↗ |
| K061206 | ACUTE BONE SCREW | Acute Innovations, LLC | 2006-06-19 | Traditional | PDF ↗ |
| K060830 | MILAGRO INTERFERENCE SCREW | Depuy Mitek, A Johnson & Johnson Company | 2006-06-15 | Traditional | PDF ↗ |
| K060249 | ULTRATINE FOREHEAD | Coapt Systems, Inc. | 2006-06-12 | Traditional | PDF ↗ |
| K060248 | ULTRATINE TRANSBLEPH | Coapt Systems, Inc. | 2006-06-12 | Traditional | PDF ↗ |
| K060914 | TRIDENT ANCHOR | Johnson & Johnson Company | 2006-06-09 | Traditional | PDF ↗ |
| K060664 | FASTIN RC ANCHOR | Depuy Mitek | 2006-06-06 | Traditional | PDF ↗ |
| K060693 | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR | Arthrotek, Inc. | 2006-06-06 | Traditional | PDF ↗ |
| K060478 | ARTHREX BIO-COMPRESSION SCREW | Arthrex, Inc. | 2006-05-19 | Traditional | PDF ↗ |
| K060271 | SPIRALOK ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2006-05-04 | Traditional | PDF ↗ |
| K060710 | UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS | Zimmer, Inc. | 2006-04-26 | Traditional | PDF ↗ |
| K060736 | SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS | Smith & Nephew, Inc. | 2006-04-18 | Special | PDF ↗ |
| K060714 | HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR | Conmed Linvatec | 2006-04-06 | Special | PDF ↗ |
| K053543 | ARTHREX ARTHOERESIS IMPLANT | Arthrex, Inc. | 2006-04-03 | Traditional | PDF ↗ |
| K060393 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | Inion , Ltd. | 2006-03-13 | Special | PDF ↗ |
| K060428 | CSS CANNULATED SCREW SYSTEM | Orthohelix Surgical Designs, Inc. | 2006-03-07 | Traditional | PDF ↗ |
| K060253 | STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. | Regeneration Technologies, Inc. | 2006-02-23 | Special | PDF ↗ |
| K053344 | BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR | Smith & Nephew, Inc. | 2006-02-23 | Traditional | PDF ↗ |
| K053561 | BIO-MINI REVO SUTURE ANCHOR | Conmed Linvatec | 2006-02-23 | Traditional | PDF ↗ |
| K053338 | ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS | Arthrex, Inc. | 2006-01-26 | Traditional | PDF ↗ |
| K060026 | KOBY SURGICAL INTERNAL FIXATION SYSTEM | Koby Surgical | 2006-01-26 | Traditional | PDF ↗ |
| K060071 | NEXA COMPRESSION SCREW | Nexa Orthopedics, Inc. | 2006-01-26 | Traditional | PDF ↗ |
| K053136 | 5TH METATARSAL FRACTURE SCREW | Wrightmedicaltechnologyinc | 2006-01-05 | Traditional | PDF ↗ |
| K053394 | NEXA BONE SCREW SYSTEM | Nexa Orthopedics, Inc. | 2005-12-14 | Traditional | PDF ↗ |
| K053093 | KALIX II IMPLANT, MODEL 141 0XX WITH XX | New Deal, S.A. | 2005-12-07 | Special | PDF ↗ |
| K052405 | STERLING INTERFERENC SCREW HT | Regeneration Technologies, Inc. | 2005-11-16 | Traditional | PDF ↗ |
| K052607 | ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS | Arthrex, Inc. | 2005-11-07 | Traditional | PDF ↗ |
| K052576 | SBI AUTOFIX | Small Bone Innovations, LLC | 2005-11-07 | Traditional | PDF ↗ |
| K050407 | LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 | Sciences For Bio Materials | 2005-11-04 | Traditional | PDF ↗ |
| K052630 | ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) | Depuy Mitek, A Johnson & Johnson Company | 2005-10-17 | Special | PDF ↗ |
| K051726 | ARTHREX TENODESIS FAMILY | Arthrex, Inc. | 2005-09-27 | Traditional | PDF ↗ |
| K050388 | REFIX INTERNAL FRACTURE FIXATION SCREWS | Xtremi-T, LLC | 2005-09-07 | Traditional | PDF ↗ |
| K051611 | MBARESORB IMPLANT | Kinetikos Medical, Inc. | 2005-09-06 | Traditional | PDF ↗ |
| K050468 | TRIABSORB COMPOSITE SCREW | Advanced Biomaterials | 2005-08-31 | Traditional | PDF ↗ |
| K052080 | MATRYX INTERFERENCE SCREW | Linvatec Biomaterials, Inc. | 2005-08-25 | Special | PDF ↗ |
| K051310 | PLC SCREW | Smith & Nephew, Inc. | 2005-07-26 | Traditional | PDF ↗ |
| K051309 | ROI FUSION RODS & PLATES | Reiley Orthopaedics, Inc. | 2005-07-11 | Traditional | PDF ↗ |
| K051323 | MERETE TWISTCUT SNAP-OFF BONE SCREW | Merete Medical GmbH | 2005-07-07 | Traditional | PDF ↗ |
| K051098 | PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES | Zimmer, Inc. | 2005-07-07 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.