Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 1997 | K973586 | SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II Spinal Concepts, Inc. | HWC |
| Oct 1, 1997 | K972494 | DEPUY DUPONT ABSORBABLE SET SCREW Depuy, Inc. | HWC |
| Oct 1, 1997 | K970912 | LEIBINGER SELF-DRILLING SCREW Howmedica Leibinger, Inc. | HWC |
| Sep 19, 1997 | K972599 | ACUFEX SCREW CANNULA Smith & Nephew Endoscopy, Inc. | HWC |
| Aug 29, 1997 | K972403 | BTI CORTICAL BONE SCREWS Biodynamic Technologies, Inc. | HWC |
| Aug 5, 1997 | K972233 | STRYKER WEDGE INTERFERENCE SCREW SYSTEM Stryker Endoscopy | HWC |
| Jul 30, 1997 | K971800 | OSTEO CANNULATED SCREW SYSTEM Osteonics Corp. | HWC |
| Jul 9, 1997 | K971654 | OSTEO COMPRESSION HIP SCREW SYSTEM Osteonics Corp. | HWC |
| Jul 9, 1997 | K971070 | SCARF THREAD-HEAD (TM) HEAD SCREW Landos, Inc. | HWC |
| Jul 9, 1997 | K971069 | TWIST-OFF (TM) SCREW Landos, Inc. | HWC |
| Jul 9, 1997 | K971068 | 34MM SCARF THREAD-HEAD(TM) SCREW Landos, Inc. | HWC |
| Jun 27, 1997 | K971778 | OSTEO SMALL AND MINI BONE SCREWS Osteonics Corp. | HWC |
| Jun 9, 1997 | K970929 | DEPUY LOW PROFILE BONE SCREW Depuy, Inc. | HWC |
| Apr 30, 1997 | K970549 | TITANIUM ALLOY BONE SCREWS Aesculap, Inc. | HWC |
| Apr 3, 1997 | K964970 | BIOMET BONE SCREW Biomet, Inc. | HWC |
| Feb 27, 1997 | K965073 | 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW Smith & Nephew, Inc. | HWC |
| Jan 22, 1997 | K963937 | NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW Northwest Precision Technologies | HWC |
| Jan 22, 1997 | K963739 | LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS Howmedica Leibinger, Inc. | HWC |
| Nov 18, 1996 | K955733 | HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) Depuy, Inc. | HWC |
| Nov 14, 1996 | K963350 | DEPUY MOTECH PEAK FIXATION SYSTEM Depuy, Inc. | HWC |
| Nov 14, 1996 | K960652 | BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. | HWC |
| Nov 13, 1996 | K962706 | EZ-FIX CANNULATED SCREW SYSTEM Biodynamic Technologies, Inc. | HWC |
| Nov 8, 1996 | K963192 | SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS Synthes (Usa) | HWC |
| Nov 8, 1996 | K963172 | SYNTHES STERILE 4.5 MM CANNULATED SCREWS Synthes (Usa) | HWC |
| Nov 4, 1996 | K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM Biodynamic Technologies, Inc. | HWC |
| Oct 10, 1996 | K963398 | ALTA FULLY THREADED CROSS-LOCKING SCREWS Howmedica Corp. | HWC |
| Oct 10, 1996 | K963118 | EXTREMITY BONE SCREW Acu Med, Inc. | HWC |
| Oct 3, 1996 | K962233 | TWIST-OFF SCREW Landos, Inc. | HWC |
| Oct 1, 1996 | K962823 | SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER Synthes (Usa) | HWC |
| Sep 20, 1996 | K962236 | SCARF THREAD-HEAD SCREW Landos, Inc. | HWC |
| Aug 23, 1996 | K962779 | COMPRESSION SCREW Orthopaedic Biosystems, Ltd. | HWC |
| Aug 19, 1996 | K960962 | INTERFERENCE SCREW Linvatec Corp. | HWC |
| Aug 15, 1996 | K960940 | BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. | HWC |
| Aug 7, 1996 | K961413 | SYNTHES ANATOMICAL LOCKING PLATE SYSTEM Synthes (Usa) | HWC |
| Aug 6, 1996 | K961905 | MEDICINELODGE, INC. SET SCREW Medicinelodge, Inc. | HWC |
| Aug 5, 1996 | K962011 | SYNTHES 7.0/7.3 MM CANNULATED SCREWS Synthes (Usa) | HWC |
| Jul 23, 1996 | K960692 | SUBTALAR MBA SYSTEM Kinetikos Medical, Inc. | HWC |
| Jul 16, 1996 | K961649 | ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER Smith & Nephew Endoscopy, Inc. | HWC |
| Jun 19, 1996 | K961234 | DEPUY ADVANTAGE FIXATION SCREW SYSTEM Depuy, Inc. | HWC |
| Jun 6, 1996 | K960704 | DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS Depuy, Inc. | HWC |
| May 17, 1996 | K961157 | WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW Whiteside Biomechanics, Inc. | HWC |
| Mar 25, 1996 | K960537 | K2 BONE SCREW SYSTEM Kinetikos Medical, Inc. | HWC |
| Mar 25, 1996 | K960533 | K3 BONE SCREW SYSTEM Kinetikos Medical, Inc. | HWC |
| Mar 22, 1996 | K925872 | NORTHO BONE SCREW Northo Orthopedics | HWC |
| Mar 4, 1996 | K955837 | CANNULATED PLUS HIP SCREW (STERILE) Wrightmedicaltechnologyinc | HWC |
| Mar 4, 1996 | K955710 | J.B.S. T.T.A SCREW J.B.S. (Usa), Inc. | HWC |
| Feb 15, 1996 | K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW Acufex Microsurgical, Inc. | HWC |
| Jan 30, 1996 | K953350 | MLI INTERFERENCE SCREW Medicinelodge, Inc. | HWC |
| Jan 25, 1996 | K954757 | FIXANO D.D.S. (DOUBLE SLIDING SCREW) Ferguson Medical | HWC |
| Jan 25, 1996 | K945303 | ARTHREX BIOABSORBABLE INTERFERENCE SCREW Arthrex, Inc. | HWC |
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