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 8 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K021233 | AAP CANNULATED SCREWS | Aap Implantate AG | 2002-12-09 | Traditional | PDF ↗ |
| K022952 | MODULAR HEAD BONE SCREW | Biomet, Inc. | 2002-12-02 | Traditional | PDF ↗ |
| K023260 | 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM | Osteomed Corp. | 2002-10-18 | Traditional | PDF ↗ |
| K021351 | BIOSTEON CROSS PIN | Biocomposites, Ltd. | 2002-10-17 | Traditional | PDF ↗ |
| K023294 | BOSWORTH CORACO-CLAVICULAR SCREW | Howmedica Osteonics Corp. | 2002-10-09 | Special | PDF ↗ |
| K023022 | NUGEN FX SCREW | Bionx Implants, Inc. | 2002-10-04 | Special | PDF ↗ |
| K023021 | MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T | Smith & Nephew, Inc. | 2002-10-04 | Special | PDF ↗ |
| K022234 | ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B | Arthrex, Inc. | 2002-10-03 | Traditional | PDF ↗ |
| K022981 | INION CPS 2.5/2.8 SCREW | Inion , Ltd. | 2002-09-12 | Special | PDF ↗ |
| K021932 | SYNTHES 6.5 MM CANNULATED SCREW | Synthes (Usa) | 2002-09-06 | Traditional | PDF ↗ |
| K022726 | STAYFUSE GT-IP | Pioneer Surgical Technology | 2002-09-06 | Traditional | PDF ↗ |
| K022647 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM | Triad Medical, Inc. | 2002-09-05 | Special | PDF ↗ |
| K021662 | MAGLY 6.5MM CANNULATED SCREWS | Magly Orthopedics, LLC | 2002-08-12 | Traditional | PDF ↗ |
| K021556 | SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW | Synthes (Usa) | 2002-08-09 | Traditional | PDF ↗ |
| K021579 | MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM | Magly Orthopedics, LLC | 2002-08-09 | Traditional | PDF ↗ |
| K020222 | WISORB MALLEOLAR SCREW | Cambridge Scientific, Inc. | 2002-07-29 | Traditional | PDF ↗ |
| K021254 | LACTOSORB MINI INTERFERENCE SCREW | Biomet Orthopedics, Inc. | 2002-07-17 | Traditional | PDF ↗ |
| K021280 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | Inion , Ltd. | 2002-07-17 | Traditional | PDF ↗ |
| K021828 | SMALL HAMMER TOE PIN | Biomet, Inc. | 2002-07-01 | Special | PDF ↗ |
| K021883 | BIOFASTIN RC THREADED SUTURE ANCHOR | Mitek Worldwide | 2002-07-01 | Special | PDF ↗ |
| K020056 | DUET SUTURE ANCHOR | Bionx Implants, Ltd. | 2002-06-26 | Traditional | PDF ↗ |
| K021832 | ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER | Biomet, Inc. | 2002-06-26 | Special | PDF ↗ |
| K021030 | TITANIUM CANNULATED INTERFERENCE SCREW | Future Medical Systems, Inc. | 2002-06-25 | Traditional | PDF ↗ |
| K013131 | BIOSCREW XTRALOK | Linvatec Corp. | 2002-06-11 | Traditional | PDF ↗ |
| K020791 | HBS HEADLESS BONE SCREW | Millennium Medical Technologies, Inc. | 2002-06-06 | Traditional | PDF ↗ |
| K020377 | PRE-LOADED BIOSTINGER HORNET | Linvatec Corp. | 2002-05-06 | Traditional | PDF ↗ |
| K020043 | 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B | Arthrex, Inc. | 2002-04-02 | Traditional | PDF ↗ |
| K014304 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S | Triage Medical, Inc. | 2002-03-27 | Traditional | PDF ↗ |
| K014243 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 | Triage Medical, Inc. | 2002-03-26 | Traditional | PDF ↗ |
| K020159 | SMITH & NEPHEW TWINFIX TI QUICK T | Smith & Nephew, Inc. | 2002-03-26 | Traditional | PDF ↗ |
| K014154 | VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 | Vilex, Inc. | 2002-03-18 | Traditional | PDF ↗ |
| K014153 | COAPT SYSTMES ENDOTINE DEVICE | Coapt Systems, Inc. | 2002-03-15 | Traditional | PDF ↗ |
| K013572 | MITEK BIOCRYL INTERFERENCE SCREWS | Mitek Products | 2002-03-14 | Special | PDF ↗ |
| K020446 | MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM | American Medical Systems, Inc. | 2002-03-13 | Special | PDF ↗ |
| K013954 | LORENZ SELF DRILLING SCREWS | Walter Lorenz Surgical, Inc. | 2002-02-28 | Traditional | PDF ↗ |
| K020352 | SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE | Unitedstates Surgical | 2002-02-26 | Special | PDF ↗ |
| K013107 | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Karl Storz Endoscopy | 2002-02-26 | Traditional | PDF ↗ |
| K020266 | INION CPS BSSO SCREW | Inion , Ltd. | 2002-02-22 | Special | PDF ↗ |
| K014185 | AOS CANNULATED BONE SCREW SYSTEM | Advanced Orthopaedic Solutions, Inc. | 2002-02-13 | Traditional | PDF ↗ |
| K013685 | PLLA CANNULATED INTERFERENCE SCREW | Future Medical Systems, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K013534 | SELF-COUNTERSINKING BONE SCREW | Biomet Orthopedics, Inc. | 2001-12-17 | Traditional | PDF ↗ |
| K013786 | DRG ORTHOHEX SS BONE SCREW | Doctor'S Research Group, Inc. | 2001-12-17 | Traditional | PDF ↗ |
| K013903 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 | Triad Medical, Inc. | 2001-12-17 | Special | PDF ↗ |
| K013890 | SURGICAL DYNAMICS MENISCAL STAPLE | United States Surgical, A Division of Tyco Healthc | 2001-12-11 | Special | PDF ↗ |
| K011451 | REUNITE FUSION SCREW | Biomet, Inc. | 2001-12-10 | Traditional | PDF ↗ |
| K012469 | RESORBABLE NO PROFILE SCREW AND WASHER | Biomet Manufacturing, Inc. | 2001-12-03 | Traditional | PDF ↗ |
| K012945 | SYNTHES 2.4 MM CANNULATED SCREW | Synthes (Usa) | 2001-12-03 | Traditional | PDF ↗ |
| K012572 | SOFT TISSUE SCREW AND WASHER | Biomet, Inc. | 2001-12-03 | Traditional | PDF ↗ |
| K013044 | SYNTHES 3.9 MM PELVIC SCREWS | Synthes (Usa) | 2001-12-03 | Traditional | PDF ↗ |
| K013546 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 | Bionx Implants, Inc. | 2001-11-21 | Special | PDF ↗ |
| K012818 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX | Triage Medical, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K012872 | RESORBABLE SCREW ANCHOR | Arthrotek, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K012817 | HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED | Triage Medical, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K012798 | INTEX SCREW | Biomet, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K011821 | MODIFICATION TO THE I.C.O.S SCREW | New Deal, S.A. | 2001-09-06 | Traditional | PDF ↗ |
| K011946 | THE SPIN SNAP-OFF SCREW | New Deal, S.A. | 2001-08-24 | Traditional | PDF ↗ |
| K012280 | TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 | Triage Medical, Inc. | 2001-08-17 | Special | PDF ↗ |
| K011102 | ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM | Aesculap, Inc. | 2001-08-03 | Traditional | PDF ↗ |
| K010738 | CANNULATED PLUS SCREW SYSTEM | Orthomatrix, Inc. | 2001-08-01 | Traditional | PDF ↗ |
| K012001 | SMARTSCREW | Bionx Implants, Ltd. | 2001-07-18 | Special | PDF ↗ |
| K012000 | 1.5MM BONE FIXATION KIT | Bionx Implants, Ltd. | 2001-07-18 | Special | PDF ↗ |
| K011910 | IN-FAST BONE SCREW SYSTEM | American Medical Systems, Inc. | 2001-07-13 | Special | PDF ↗ |
| K010964 | AUTO-DRIVE LAG SCREW SYSTEM | Osteomed Corp. | 2001-07-05 | Traditional | PDF ↗ |
| K011719 | PLUS CANCELLOUS BONE SCREWS | Plus Orthopedics | 2001-07-02 | Special | PDF ↗ |
| K010884 | TITANIUM COMPRESSION ANCHOR SYSTEM | Anchor Medical Technologies | 2001-06-20 | Traditional | PDF ↗ |
| K011262 | MODIFICATION TO THE BOLD SCREW | New Deal, S.A. | 2001-06-15 | Traditional | PDF ↗ |
| K010783 | 2.0/2.4 CANNULATED SCREW SYSTEM | Osteomed Corp. | 2001-05-30 | Traditional | PDF ↗ |
| K010594 | DJ ORTHOPEDICS POST SCREW | Dj Orthopedics, LLC | 2001-05-29 | Traditional | PDF ↗ |
| K010554 | MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A | Bionx Implants, Inc. | 2001-05-25 | Traditional | PDF ↗ |
| K010525 | ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM | Arthrex, Inc. | 2001-05-23 | Traditional | PDF ↗ |
| K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM | Mitek Products | 2001-05-09 | Traditional | PDF ↗ |
| K010595 | DJ ORTHOPEDICS INTERFERENCE SCREW | Dj Orthopedics, LLC | 2001-05-08 | Traditional | PDF ↗ |
| K003077 | SMARTSCREW MODEL 222006...227510 | Bionx Implants, Ltd. | 2001-04-26 | Traditional | PDF ↗ |
| K001581 | LACTOSORB 5.0 MM WASHER | Biomet, Inc. | 2001-03-20 | Traditional | PDF ↗ |
| K003816 | ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM | Arthrex, Inc. | 2001-03-09 | Traditional | PDF ↗ |
| K002274 | SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW | Smith & Nephew, Inc. | 2001-03-07 | Traditional | PDF ↗ |
| K003700 | SYNTHES HAMSTRING LOOP | Synthes (Usa) | 2001-02-20 | Traditional | PDF ↗ |
| K003599 | SMITH & NEPHEW SUTURE ANCHOR | Smith & Nephew, Inc. | 2001-02-15 | Traditional | PDF ↗ |
| K003641 | BIOLOK SCREW, BIOSTEON SCREW | Biocomposites, Ltd. | 2001-02-08 | Traditional | PDF ↗ |
| K002654 | HOWMEDICA OSTEONICS SHOULDER SCREW | Howmedica Osteonics Corp. | 2000-09-22 | Special | PDF ↗ |
| K002271 | 2.4MM CORTEX SCREW, SELF-TAPPING | Synthes (Usa) | 2000-08-25 | Traditional | PDF ↗ |
| K002070 | BIOLOK SCREW | Biocomposites, Ltd. | 2000-08-25 | Traditional | PDF ↗ |
| K993166 | STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | 2000-08-04 | Traditional | PDF ↗ |
| K001231 | THE KALIX IMPLANT | New Deal, S.A. | 2000-07-11 | Traditional | PDF ↗ |
| K993630 | BIOLOK SCREW | Encore Orthopedics, Inc. | 2000-04-26 | Traditional | PDF ↗ |
| K000080 | ASNIS III CANNULATED SCREW SYSTEM | Howmedica Osteonics Corp. | 2000-04-03 | Traditional | PDF ↗ |
| K994382 | NONLINEAR TAPER LAG SCREW | Theken Surgical | 2000-03-10 | Traditional | PDF ↗ |
| K994152 | THE LIGAMENT ANCHOR SOFT SCREW | Corin USA | 2000-03-06 | Traditional | PDF ↗ |
| K994202 | ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM | Smith & Nephew, Inc. | 2000-02-25 | Traditional | PDF ↗ |
| K993762 | I.CO.S SCREW | New Deal, S.A. | 2000-02-04 | Traditional | PDF ↗ |
| K000089 | SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS | Synthes (Usa) | 2000-02-03 | Traditional | PDF ↗ |
| K992396 | BIORCI SCREW | Smith & Nephew Endoscopy, Inc. | 2000-01-12 | Traditional | PDF ↗ |
| K993975 | ABSOLUTE ABSORBABLE INTERFERENCE SCREW | Innovasive Devices, Inc. | 1999-12-20 | Special | PDF ↗ |
| K991964 | EIS THREADED SCREW FRACTURE FIXATION | Groupe Lepine | 1999-12-20 | Traditional | PDF ↗ |
| K992945 | RCI FIXATION SCREWS (WITH ASSORTED SIZES) | Smith & Nephew, Inc. | 1999-11-18 | Traditional | PDF ↗ |
| K991024 | BONE BULLET SUTURE ANCHOR | Linvatec Corp. | 1999-11-16 | Traditional | PDF ↗ |
| K993025 | MODIFICATION TO BONE MULCH SCREW SYSTEM | Biomet, Inc. | 1999-10-08 | Special | PDF ↗ |
| K992367 | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS | Electro-Biology, Inc. | 1999-09-23 | Traditional | PDF ↗ |
| K992611 | MITEK ROTATOR CUFF QUICKANCHOR PLUS | Mitek Products | 1999-09-22 | Traditional | PDF ↗ |
| K992487 | MITEK MINI QUICKANCHOR PLUS | Mitek Products | 1999-09-21 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.