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 |
|---|---|---|---|
| Dec 19, 1995 | K954511 | GO INTRAMEDULLARY NAIL LOCKING SCREW Genesis Orthopedics, Inc. | HWC |
| Dec 8, 1995 | K954330 | SUPER SCREW 3.5 MM Osteomed Corp. | HWC |
| Nov 24, 1995 | K953198 | CORTICELLOUS BONE SCREW Hayes Medical, Inc. | HWC |
| Nov 3, 1995 | K953650 | DEPUY STAINLESS STEEL SET SCREW Depuy, Inc. | HWC |
| Oct 31, 1995 | K954485 | 6.5MM SOLID CANCELLOUS BONE SCREW Ace Medical Co. | HWC |
| Sep 28, 1995 | K952460 | STRYKER ACL INTERFERENCE SCREW SYSTEM Stryker Endoscopy | HWC |
| Sep 15, 1995 | K952831 | BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. | HWC |
| Sep 12, 1995 | K952697 | TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM Smith & Nephew Richards, Inc. | HWC |
| Aug 25, 1995 | K951232 | EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM American Medical Electronics, Inc. | HWC |
| Aug 18, 1995 | K952296 | SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW Synthes (Usa) | HWC |
| Jul 31, 1995 | K952272 | TI. ALLOY 2.0 MM CORTEX SCREW Synthes (Usa) | HWC |
| Jul 24, 1995 | K951389 | REUNION BONE SCREW SYSTEM Smith & Nephew Richards, Inc. | HWC |
| Jul 18, 1995 | K951656 | NEXMED CANCELLOUS BONE SCREWS Nexmed, Inc. | HWC |
| Jul 11, 1995 | K950875 | OGDEN ANCHOR American Medical Electronics, Inc. | HWC |
| Jul 11, 1995 | K946347 | ABSORBABLE ACETABULAR SCREW Zimmer, Inc. | HWC |
| Jul 11, 1995 | K945525 | ANSPACH SUTURE ANCHOR The Anspach Effort, Inc. | HWC |
| Jul 10, 1995 | K950833 | DEPUY SET SCREW Depuy, Inc. | HWC |
| Jul 5, 1995 | K932350 | ORTHOPEDIC SCREW FIXATION Osteomed Corp. | HWC |
| Jul 3, 1995 | K951545 | OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS American Medical Electronics, Inc. | HWC |
| Jul 3, 1995 | K951493 | OGDEN ANCHOR American Medical Electronics, Inc. | HWC |
| Jul 3, 1995 | K951472 | LMT BONE ANCHOR Li Medical Technologies, Inc. | HWC |
| Jul 3, 1995 | K951233 | LMT BONE ANCHOR Li Medical Technologies, Inc. | HWC |
| Jul 3, 1995 | K943806 | HARPOON SUTURE ANCHORS Biomet, Inc. | HWC |
| Jun 30, 1995 | K950704 | K4 BONE SCREW SYSTEM Kinetikos Medical, Inc. | HWC |
| Jun 27, 1995 | K951303 | SFC Medpac | HWC |
| Jun 22, 1995 | K950652 | OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS Osteotech, Inc. | HWC |
| Jun 22, 1995 | K945687 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW Smith and Nephew Donjoy, Inc. | HWC |
| Jun 16, 1995 | K951304 | SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER Synthes (Usa) | HWC |
| Jun 14, 1995 | K934590 | IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS Smith & Nephew Richards, Inc. | HWC |
| May 17, 1995 | K950250 | MED-SURG SUTURE WASHER Medical Surgical, Inc. | HWC |
| May 10, 1995 | K934321 | LINVATEC STASYS-PES FIXATION DEVICE Linvatec Corp. | HWC |
| May 5, 1995 | K944330 | ACUTRAK PLUS FIXATION SYSTEM Acu Med, Inc. | HWC |
| Apr 14, 1995 | K945426 | ARTHREX CANCELLOUS SCREW AND WASHER Arthrex, Inc. | HWC |
| Feb 3, 1995 | K945236 | AIMS CANNULATED ACL SCREW (7MM DIAMETER) Smith and Nephew Donjoy, Inc. | HWC |
| Feb 2, 1995 | K941941 | BONE MULCH SCREW Biomet, Inc. | HWC |
| Jan 24, 1995 | K945182 | DYONICS FIXATION SCREWS Smith & Nephew Dyonics, Inc. | HWC |
| Dec 9, 1994 | K944213 | 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW Howmedica Corp. | HWC |
| Dec 8, 1994 | K943804 | BONE SCREW Cohort Medical Products Group, Inc. | HWC |
| Dec 5, 1994 | K942341 | CANNULATED CANCELLOUS BONE SCREW Acu Med, Inc. | HWC |
| Dec 5, 1994 | K942340 | CORTICAL BONE SCREW Acu Med, Inc. | HWC |
| Nov 28, 1994 | K941866 | PIONEER LABORATORIES CABLE SCREW Pioneer Surgical Technology | HWC |
| Nov 22, 1994 | K940690 | PIONEER LABORATORIES BONE SCREW Pioneer Surgical Technology | HWC |
| Oct 19, 1994 | K943539 | AIMS CANNULATED ACL SCREW Smith & Nephew, Inc. | HWC |
| Oct 14, 1994 | K943474 | CANNULATED BONE SCREW Cohort Medical Products Group, Inc. | HWC |
| Oct 7, 1994 | K934366 | MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER Mitek Surgical Products, Inc. | HWC |
| Sep 30, 1994 | K943160 | INTERFERENCE SCREW Applied Osteo Systems, Inc. | HWC |
| Sep 19, 1994 | K941174 | PIONEER LABORATORIES CABLE PIN Pioneer Surgical Technology | HWC |
| Sep 1, 1994 | K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE Roseburg SA | HWC |
| Aug 1, 1994 | K932721 | ARTHROTEK SET SCREW Biomet, Inc. | HWC |
| Jul 12, 1994 | K940207 | TITANIUM ALLOY BONE SCREWS Aesculap, Inc. | HWC |
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