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 |
|---|---|---|---|
| May 17, 1994 | K933719 | BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. | HWC |
| May 4, 1994 | K931680 | CANNULATED CANCELLOUS SCREW Onyx Medical Corp. | HWC |
| May 4, 1994 | K931538 | AMSET(TM) CANNULATED BONE SCREW Advanced Med/Surg, Inc. | HWC |
| Apr 28, 1994 | K931652 | ACE 6.5 MM BONE SCREW Ace Medical Co. | HWC |
| Apr 25, 1994 | K934616 | CANCELLOUS BONE SCREW Onyx Medical Corp. | HWC |
| Apr 25, 1994 | K934615 | CANCELLOUS BONE SCREW Onyx Medical Corp. | HWC |
| Apr 25, 1994 | K931790 | CORTICAL BONE SCREW Onyx Medical Corp. | HWC |
| Apr 25, 1994 | K931681 | CANNULATED NAVICULAR SCREW Onyx Medical Corp. | HWC |
| Apr 15, 1994 | K935836 | BONE OR INTERFERENCE SCREW Endo Surgical Concepts, Inc. | HWC |
| Mar 10, 1994 | K934044 | ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM Smith and Nephew Donjoy, Inc. | HWC |
| Mar 10, 1994 | K932862 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW Smith and Nephew Donjoy, Inc. | HWC |
| Mar 1, 1994 | K931524 | FULLY THREADED ALTA CANCELLOUS BONE SCREW Howmedica Corp. | HWC |
| Feb 23, 1994 | K934469 | ARTHROTEK INTERFERENCE SCREW Biomet, Inc. | HWC |
| Feb 23, 1994 | K933738 | M. KUROSAKA INTERFERENCE FIXATION SCREW Depuy, Inc. | HWC |
| Feb 23, 1994 | K933352 | CONCEPT CANNULATED INTEREFERENCE SCREW Linvatec Corp. | HWC |
| Feb 23, 1994 | K932027 | OREGON FIXATION SYSTEM INTERFERENCE SCREW Acu Med, Inc. | HWC |
| Feb 22, 1994 | K930107 | AME UNIVERSAL BONE SCREW American Medical Electronics, Inc. | HWC |
| Feb 17, 1994 | K931665 | 6.5 MM CANCELLOUS BONE SCREW Encore Orthopedics, Inc. | HWC |
| Feb 10, 1994 | K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW Instrument Makar, Inc. | HWC |
| Feb 7, 1994 | K931187 | IMPLEX ACETABULAR CUP SCREW SYSTEM Implex Corp. | HWC |
| Jan 7, 1994 | K930970 | BAUMER SCREWS Baumer Ortopedia , Ltd., BR | HWC |
| Oct 27, 1993 | K925328 | ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR Anspach Mfg., Inc. | HWC |
| Oct 27, 1993 | K923841 | BONE SCREWS Instrument Makar, Inc. | HWC |
| Aug 24, 1993 | K921481 | INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR Acufex Microsurgical, Inc. | HWC |
| Jul 26, 1993 | K930834 | ACUTRACT Acu Med, Inc. | HWC |
| Apr 6, 1993 | K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE Techmedica, Inc. | HWC |
| Apr 1, 1993 | K924018 | M3 LAG SCREW FIXATION SYSTEM Osteomed Corp. | HWC |
| Mar 31, 1993 | K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW Ace Orthopedic Manufacturing Co. | HWC |
| Mar 19, 1993 | K923477 | 3.5MM UNIVERSAL COMPRESSION SCREW Howmedica Corp. | HWC |
| Mar 12, 1993 | K922788 | BIOACTION LOW PROFILE SCREW SYSTEM Orthopaedic Biosystems | HWC |
| Feb 9, 1993 | K915424 | ARTHREX CANNULATED INTERFERENCE SCREW Arthrex, Inc. | HWC |
| Oct 13, 1992 | K924514 | ACUFEX FIXATION POST Acufex Microsurgical, Inc. | HWC |
| Oct 9, 1992 | K923256 | ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW Alphatec Mfg., Inc. | HWC |
| Aug 6, 1992 | K922166 | ALPHATEC SMALL FRAGMENT SET Alphatec Mfg., Inc. | HWC |
| Aug 5, 1992 | K922322 | ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW Alphatec Mfg., Inc. | HWC |
| May 1, 1992 | K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE Concept, Inc. | HWC |
| Feb 28, 1992 | K915448 | CORTICAL BONE SCREW Dow Corning Wright | HWC |
| Feb 14, 1992 | K915316 | AAP BONE SCREW Aap International, Ltd. | HWC |
| Feb 13, 1992 | K915613 | BONE SCREW 3.5 MM Acu Med, Inc. | HWC |
| Feb 11, 1992 | K915124 | UNIVERSAL COMPRESION SCREW Howmedica Corp. | HWC |
| Jan 24, 1992 | K913210 | M. KUROSAKA(TM) FIXATION SCREW Depuy, Inc. | HWC |
| Jan 13, 1992 | K910976 | OREGON FIXATION SCREW Acu Med, Inc. | HWC |
| Dec 19, 1991 | K915187 | CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW Techmedica, Inc. | HWC |
| Dec 5, 1991 | K914004 | ALPHATEC CANNULATED BONE SCREWS Alphatec Mfg., Inc. | HWC |
| Nov 27, 1991 | K912598 | ACE CORTICAL BONE SCREW Ace Medical Co. | HWC |
| Nov 22, 1991 | K913269 | OSTEO BONE SCREWS Fred C. Bryson | HWC |
| Nov 22, 1991 | K912021 | MAKAR MINI CANNULATED CANCELLOUS SCREWS Instrument Makar, Inc. | HWC |
| Oct 29, 1991 | K913415 | AESCULAP TITANIUM BONE SCREWS Aesculap, Inc. | HWC |
| Oct 4, 1991 | K911768 | AMSET(TM) BONE SCREW Advanced Med/Surg, Inc. | HWC |
| Aug 23, 1991 | K910193 | HUENE FIXATION SCREW Acu-Med, Inc. | HWC |
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