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 9 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K992947 | CANNULATED SMARTSCREW MODELS 224540C, 224570C | Bionx Implants, Ltd. | 1999-09-21 | Special | PDF ↗ |
| K992106 | MODUS SYSTEM SELF-DRILLING SCREWS | Medartis AG | 1999-09-17 | Traditional | PDF ↗ |
| K990194 | BIOBUTTON | Linvatec Corp. | 1999-09-17 | Traditional | PDF ↗ |
| K992301 | REUNITE SCREWS | Biomet Manufacturing, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K990770 | BIORC ANCHOR | Linvatec Corp. | 1999-07-30 | Traditional | PDF ↗ |
| K992277 | STAPLETAC BONE ANCHOR SYSTEM | Influence, Inc. | 1999-07-30 | Special | PDF ↗ |
| K991477 | SPIN SNAP-OFF SCREW | New Deal, S.A. | 1999-07-14 | Traditional | PDF ↗ |
| K990454 | BIO-INTERFERENCE SCREW | Innovasive Devices, Inc. | 1999-07-01 | Traditional | PDF ↗ |
| K990351 | BONE SCREWS | Bregma International Trading Company , Ltd. | 1999-06-01 | Traditional | PDF ↗ |
| K991298 | BONE MULCH SCREW SYSTEM | Biomet, Inc. | 1999-05-14 | Traditional | PDF ↗ |
| K990804 | STAYFUSE | Pioneer Surgical Technology | 1999-04-29 | Traditional | PDF ↗ |
| K990776 | AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM | Aap Implantate AG | 1999-04-29 | Traditional | PDF ↗ |
| K990622 | BOLD SCREW | New Deal, S.A. | 1999-04-29 | Traditional | PDF ↗ |
| K991151 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW | Vilex, Inc. | 1999-04-26 | Traditional | PDF ↗ |
| K991197 | VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24 | Vilex, Inc. | 1999-04-26 | Traditional | PDF ↗ |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | Biodynamic Technologies, Inc. | 1999-03-17 | Traditional | PDF ↗ |
| K990019 | DRG MEDIUM SCREW SYSTEM | Dolphin Medical Technologies, Inc. | 1999-03-15 | Traditional | PDF ↗ |
| K984209 | STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED | Biomet, Inc. | 1999-02-03 | Traditional | PDF ↗ |
| K984320 | BIOABSORBABLE INTERFERENCE SCREWS | Smith & Nephew, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K983592 | SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS | Sulzer Orthopedics, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K984331 | ODI ULTIMATE COMPRESSION HIP SCREW | Orthopedic Designs, Inc. | 1999-01-20 | Traditional | PDF ↗ |
| K970829 | PHUSIS ABSORBABLE INTERFERENCE SCREW | Tornier | 1998-12-22 | Traditional | PDF ↗ |
| K983495 | SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 | Syntec Scientific Corp. | 1998-12-16 | Traditional | PDF ↗ |
| K983508 | OSTEO COMPRESSION CONDYLE SCREW SYSTEM | Osteonics Corp. | 1998-12-07 | Traditional | PDF ↗ |
| K983165 | OSTEO 4.0MM CANNULATED SCREW SYSTEM | Osteonics Corp. | 1998-12-03 | Traditional | PDF ↗ |
| K983006 | OSTEO 5.0MM CANNULATED SCREW SYSTEM | Stryker Osteonics | 1998-11-23 | Traditional | PDF ↗ |
| K982662 | DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW | DePuy Orthopaedics, Inc. | 1998-10-28 | Traditional | PDF ↗ |
| K982497 | ARTHROTEK INTERFERENCE SCREW | Biomet, Inc. | 1998-10-16 | Traditional | PDF ↗ |
| K980457 | ENDO ABSORBABLE INTERFERENCE SCREW | Endo Surgical Concepts, Inc. | 1998-09-08 | Traditional | PDF ↗ |
| K982222 | SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM | Synthes (Usa) | 1998-07-29 | Traditional | PDF ↗ |
| K981187 | ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 | Arthrex, Inc. | 1998-07-01 | Traditional | PDF ↗ |
| K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM | Buckman Co., Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K981670 | DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW | Depuy, Inc. | 1998-06-22 | Traditional | PDF ↗ |
| K980841 | RCI FIXATION SCREWS | Smith & Nephew, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K981372 | SYNTHES 3.0 MM PC-FIX SYSTEM | Synthes (Usa) | 1998-05-11 | Traditional | PDF ↗ |
| K981259 | OSTEO 4.0MM CANNULATED SCREW SYSTEM | Osteonics Corp. | 1998-05-11 | Traditional | PDF ↗ |
| K980364 | HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS | Howmedica Corp. | 1998-04-29 | Traditional | PDF ↗ |
| K980681 | INNOVASIVE DEVICES MENISCAL SCREW | Innovasive Devices, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K980440 | DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW | Depuy, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K972919 | BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW | Bionx Implants, Inc. | 1998-03-27 | Traditional | PDF ↗ |
| K974785 | AUTO-DRIVE BONE SCREW | Osteomed Corp. | 1998-03-18 | Traditional | PDF ↗ |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | Biodynamic Technologies, Inc. | 1998-03-12 | Traditional | PDF ↗ |
| K974538 | MENISCAL REPAIR DEVICE | Linvatec Corp. | 1998-03-03 | Traditional | PDF ↗ |
| K973758 | BIOSCREW ABSORBABLE INTERFERENCE SREW | Linvatec Corp. | 1998-02-27 | Traditional | PDF ↗ |
| K972722 | ULTIMATE COMPRESSION SCREW SYSTEM | Orthopedic Designs, Inc. | 1998-01-23 | Traditional | PDF ↗ |
| K973309 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW | Vilex, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K973810 | DRG LARGE SCREW SYSTEM | Dolphin Medical Technologies, Inc. | 1998-01-05 | Traditional | PDF ↗ |
| K972217 | ORTHOPEDIC SCREW SYSTEM | Ferguson Medical | 1997-11-20 | Traditional | PDF ↗ |
| K973005 | THE CORIFIX LIGAMENT ANCHOR | Corin USA | 1997-11-10 | Traditional | PDF ↗ |
| K973586 | SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II | Spinal Concepts, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K970912 | LEIBINGER SELF-DRILLING SCREW | Howmedica Leibinger, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K972494 | DEPUY DUPONT ABSORBABLE SET SCREW | Depuy, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K972599 | ACUFEX SCREW CANNULA | Smith & Nephew Endoscopy, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K972403 | BTI CORTICAL BONE SCREWS | Biodynamic Technologies, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K972233 | STRYKER WEDGE INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | 1997-08-05 | Traditional | PDF ↗ |
| K971800 | OSTEO CANNULATED SCREW SYSTEM | Osteonics Corp. | 1997-07-30 | Traditional | PDF ↗ |
| K971654 | OSTEO COMPRESSION HIP SCREW SYSTEM | Osteonics Corp. | 1997-07-09 | Traditional | PDF ↗ |
| K971068 | 34MM SCARF THREAD-HEAD(TM) SCREW | Landos, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K971070 | SCARF THREAD-HEAD (TM) HEAD SCREW | Landos, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K971069 | TWIST-OFF (TM) SCREW | Landos, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K971778 | OSTEO SMALL AND MINI BONE SCREWS | Osteonics Corp. | 1997-06-27 | Traditional | PDF ↗ |
| K970929 | DEPUY LOW PROFILE BONE SCREW | Depuy, Inc. | 1997-06-09 | Traditional | PDF ↗ |
| K970549 | TITANIUM ALLOY BONE SCREWS | Aesculap, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K964970 | BIOMET BONE SCREW | Biomet, Inc. | 1997-04-03 | Traditional | PDF ↗ |
| K965073 | 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW | Smith & Nephew, Inc. | 1997-02-27 | Traditional | PDF ↗ |
| K963937 | NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW | Northwest Precision Technologies | 1997-01-22 | Traditional | PDF ↗ |
| K963739 | LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS | Howmedica Leibinger, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K955733 | HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) | Depuy, Inc. | 1996-11-18 | Traditional | PDF ↗ |
| K960652 | BIOSCREW ABSORBABLE INTERFERENCE SCREW | Linvatec Corp. | 1996-11-14 | Traditional | PDF ↗ |
| K963350 | DEPUY MOTECH PEAK FIXATION SYSTEM | Depuy, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | Biodynamic Technologies, Inc. | 1996-11-13 | Traditional | PDF ↗ |
| K963192 | SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS | Synthes (Usa) | 1996-11-08 | Traditional | PDF ↗ |
| K963172 | SYNTHES STERILE 4.5 MM CANNULATED SCREWS | Synthes (Usa) | 1996-11-08 | Traditional | PDF ↗ |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | Biodynamic Technologies, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K963118 | EXTREMITY BONE SCREW | Acu Med, Inc. | 1996-10-10 | Traditional | PDF ↗ |
| K963398 | ALTA FULLY THREADED CROSS-LOCKING SCREWS | Howmedica Corp. | 1996-10-10 | Traditional | PDF ↗ |
| K962233 | TWIST-OFF SCREW | Landos, Inc. | 1996-10-03 | Traditional | PDF ↗ |
| K962823 | SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER | Synthes (Usa) | 1996-10-01 | Traditional | PDF ↗ |
| K962236 | SCARF THREAD-HEAD SCREW | Landos, Inc. | 1996-09-20 | Traditional | PDF ↗ |
| K962779 | COMPRESSION SCREW | Orthopaedic Biosystems, Ltd. | 1996-08-23 | Traditional | PDF ↗ |
| K960962 | INTERFERENCE SCREW | Linvatec Corp. | 1996-08-19 | Traditional | PDF ↗ |
| K960940 | BIOSCREW ABSORBABLE INTERFERENCE SCREW | Linvatec Corp. | 1996-08-15 | Traditional | PDF ↗ |
| K961413 | SYNTHES ANATOMICAL LOCKING PLATE SYSTEM | Synthes (Usa) | 1996-08-07 | Traditional | PDF ↗ |
| K961905 | MEDICINELODGE, INC. SET SCREW | Medicinelodge, Inc. | 1996-08-06 | Traditional | PDF ↗ |
| K962011 | SYNTHES 7.0/7.3 MM CANNULATED SCREWS | Synthes (Usa) | 1996-08-05 | Traditional | PDF ↗ |
| K960692 | SUBTALAR MBA SYSTEM | Kinetikos Medical, Inc. | 1996-07-23 | Traditional | PDF ↗ |
| K961649 | ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER | Smith & Nephew Endoscopy, Inc. | 1996-07-16 | Traditional | PDF ↗ |
| K961234 | DEPUY ADVANTAGE FIXATION SCREW SYSTEM | Depuy, Inc. | 1996-06-19 | Traditional | PDF ↗ |
| K960704 | DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS | Depuy, Inc. | 1996-06-06 | Traditional | PDF ↗ |
| K961157 | WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW | Whiteside Biomechanics, Inc. | 1996-05-17 | Traditional | PDF ↗ |
| K960537 | K2 BONE SCREW SYSTEM | Kinetikos Medical, Inc. | 1996-03-25 | Traditional | PDF ↗ |
| K960533 | K3 BONE SCREW SYSTEM | Kinetikos Medical, Inc. | 1996-03-25 | Traditional | PDF ↗ |
| K925872 | NORTHO BONE SCREW | Northo Orthopedics | 1996-03-22 | Traditional | PDF ↗ |
| K955837 | CANNULATED PLUS HIP SCREW (STERILE) | Wrightmedicaltechnologyinc | 1996-03-04 | Traditional | PDF ↗ |
| K955710 | J.B.S. T.T.A SCREW | J.B.S. (Usa), Inc. | 1996-03-04 | Traditional | PDF ↗ |
| K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW | Acufex Microsurgical, Inc. | 1996-02-15 | Traditional | PDF ↗ |
| K953350 | MLI INTERFERENCE SCREW | Medicinelodge, Inc. | 1996-01-30 | Traditional | PDF ↗ |
| K954757 | FIXANO D.D.S. (DOUBLE SLIDING SCREW) | Ferguson Medical | 1996-01-25 | Traditional | PDF ↗ |
| K945303 | ARTHREX BIOABSORBABLE INTERFERENCE SCREW | Arthrex, Inc. | 1996-01-25 | Traditional | PDF ↗ |
| K954511 | GO INTRAMEDULLARY NAIL LOCKING SCREW | Genesis Orthopedics, Inc. | 1995-12-19 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.