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 10 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K954330 | SUPER SCREW 3.5 MM | Osteomed Corp. | 1995-12-08 | Traditional | PDF ↗ |
| K953198 | CORTICELLOUS BONE SCREW | Hayes Medical, Inc. | 1995-11-24 | Traditional | PDF ↗ |
| K953650 | DEPUY STAINLESS STEEL SET SCREW | Depuy, Inc. | 1995-11-03 | Traditional | PDF ↗ |
| K954485 | 6.5MM SOLID CANCELLOUS BONE SCREW | Ace Medical Co. | 1995-10-31 | Traditional | PDF ↗ |
| K952460 | STRYKER ACL INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | 1995-09-28 | Traditional | PDF ↗ |
| K952831 | BIOSCREW ABSORBABLE INTERFERENCE SCREW | Linvatec Corp. | 1995-09-15 | Traditional | PDF ↗ |
| K952697 | TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM | Smith & Nephew Richards, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K951232 | EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM | American Medical Electronics, Inc. | 1995-08-25 | Traditional | PDF ↗ |
| K952296 | SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW | Synthes (Usa) | 1995-08-18 | Traditional | PDF ↗ |
| K952272 | TI. ALLOY 2.0 MM CORTEX SCREW | Synthes (Usa) | 1995-07-31 | Traditional | PDF ↗ |
| K951389 | REUNION BONE SCREW SYSTEM | Smith & Nephew Richards, Inc. | 1995-07-24 | Traditional | PDF ↗ |
| K951656 | NEXMED CANCELLOUS BONE SCREWS | Nexmed, Inc. | 1995-07-18 | Traditional | PDF ↗ |
| K946347 | ABSORBABLE ACETABULAR SCREW | Zimmer, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K945525 | ANSPACH SUTURE ANCHOR | The Anspach Effort, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K950875 | OGDEN ANCHOR | American Medical Electronics, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K950833 | DEPUY SET SCREW | Depuy, Inc. | 1995-07-10 | Traditional | PDF ↗ |
| K932350 | ORTHOPEDIC SCREW FIXATION | Osteomed Corp. | 1995-07-05 | Traditional | PDF ↗ |
| K943806 | HARPOON SUTURE ANCHORS | Biomet, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K951472 | LMT BONE ANCHOR | Li Medical Technologies, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K951493 | OGDEN ANCHOR | American Medical Electronics, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K951545 | OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS | American Medical Electronics, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K951233 | LMT BONE ANCHOR | Li Medical Technologies, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K950704 | K4 BONE SCREW SYSTEM | Kinetikos Medical, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K951303 | SFC | Medpac | 1995-06-27 | Traditional | PDF ↗ |
| K945687 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW | Smith and Nephew Donjoy, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K950652 | OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS | Osteotech, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K951304 | SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER | Synthes (Usa) | 1995-06-16 | Traditional | PDF ↗ |
| K934590 | IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS | Smith & Nephew Richards, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K950250 | MED-SURG SUTURE WASHER | Medical Surgical, Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K934321 | LINVATEC STASYS-PES FIXATION DEVICE | Linvatec Corp. | 1995-05-10 | Traditional | PDF ↗ |
| K944330 | ACUTRAK PLUS FIXATION SYSTEM | Acu Med, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K945426 | ARTHREX CANCELLOUS SCREW AND WASHER | Arthrex, Inc. | 1995-04-14 | Traditional | PDF ↗ |
| K945236 | AIMS CANNULATED ACL SCREW (7MM DIAMETER) | Smith and Nephew Donjoy, Inc. | 1995-02-03 | Traditional | PDF ↗ |
| K941941 | BONE MULCH SCREW | Biomet, Inc. | 1995-02-02 | Traditional | PDF ↗ |
| K945182 | DYONICS FIXATION SCREWS | Smith & Nephew Dyonics, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K944213 | 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW | Howmedica Corp. | 1994-12-09 | Traditional | PDF ↗ |
| K943804 | BONE SCREW | Cohort Medical Products Group, Inc. | 1994-12-08 | Traditional | PDF ↗ |
| K942341 | CANNULATED CANCELLOUS BONE SCREW | Acu Med, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K942340 | CORTICAL BONE SCREW | Acu Med, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K941866 | PIONEER LABORATORIES CABLE SCREW | Pioneer Surgical Technology | 1994-11-28 | Traditional | PDF ↗ |
| K940690 | PIONEER LABORATORIES BONE SCREW | Pioneer Surgical Technology | 1994-11-22 | Traditional | PDF ↗ |
| K943539 | AIMS CANNULATED ACL SCREW | Smith & Nephew, Inc. | 1994-10-19 | Traditional | PDF ↗ |
| K943474 | CANNULATED BONE SCREW | Cohort Medical Products Group, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K934366 | MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER | Mitek Surgical Products, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K943160 | INTERFERENCE SCREW | Applied Osteo Systems, Inc. | 1994-09-30 | Traditional | PDF ↗ |
| K941174 | PIONEER LABORATORIES CABLE PIN | Pioneer Surgical Technology | 1994-09-19 | Traditional | PDF ↗ |
| K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE | Roseburg SA | 1994-09-01 | Traditional | PDF ↗ |
| K932721 | ARTHROTEK SET SCREW | Biomet, Inc. | 1994-08-01 | Traditional | PDF ↗ |
| K940207 | TITANIUM ALLOY BONE SCREWS | Aesculap, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K933719 | BIOSCREW ABSORBABLE INTERFERENCE SCREW | Linvatec Corp. | 1994-05-17 | Traditional | PDF ↗ |
| K931538 | AMSET(TM) CANNULATED BONE SCREW | Advanced Med/Surg, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K931680 | CANNULATED CANCELLOUS SCREW | Onyx Medical Corp. | 1994-05-04 | Traditional | PDF ↗ |
| K931652 | ACE 6.5 MM BONE SCREW | Ace Medical Co. | 1994-04-28 | Traditional | PDF ↗ |
| K934616 | CANCELLOUS BONE SCREW | Onyx Medical Corp. | 1994-04-25 | Traditional | PDF ↗ |
| K931790 | CORTICAL BONE SCREW | Onyx Medical Corp. | 1994-04-25 | Traditional | PDF ↗ |
| K931681 | CANNULATED NAVICULAR SCREW | Onyx Medical Corp. | 1994-04-25 | Traditional | PDF ↗ |
| K934615 | CANCELLOUS BONE SCREW | Onyx Medical Corp. | 1994-04-25 | Traditional | PDF ↗ |
| K935836 | BONE OR INTERFERENCE SCREW | Endo Surgical Concepts, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K934044 | ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM | Smith and Nephew Donjoy, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K932862 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW | Smith and Nephew Donjoy, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K931524 | FULLY THREADED ALTA CANCELLOUS BONE SCREW | Howmedica Corp. | 1994-03-01 | Traditional | PDF ↗ |
| K934469 | ARTHROTEK INTERFERENCE SCREW | Biomet, Inc. | 1994-02-23 | Traditional | PDF ↗ |
| K932027 | OREGON FIXATION SYSTEM INTERFERENCE SCREW | Acu Med, Inc. | 1994-02-23 | Traditional | PDF ↗ |
| K933352 | CONCEPT CANNULATED INTEREFERENCE SCREW | Linvatec Corp. | 1994-02-23 | Traditional | PDF ↗ |
| K933738 | M. KUROSAKA INTERFERENCE FIXATION SCREW | Depuy, Inc. | 1994-02-23 | Traditional | PDF ↗ |
| K930107 | AME UNIVERSAL BONE SCREW | American Medical Electronics, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K931665 | 6.5 MM CANCELLOUS BONE SCREW | Encore Orthopedics, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW | Instrument Makar, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K931187 | IMPLEX ACETABULAR CUP SCREW SYSTEM | Implex Corp. | 1994-02-07 | Traditional | PDF ↗ |
| K930970 | BAUMER SCREWS | Baumer Ortopedia , Ltd. | 1994-01-07 | Traditional | PDF ↗ |
| K923841 | BONE SCREWS | Instrument Makar, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K925328 | ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR | Anspach Mfg., Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K921481 | INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR | Acufex Microsurgical, Inc. | 1993-08-24 | Traditional | PDF ↗ |
| K930834 | ACUTRACT | Acu Med, Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE | Techmedica, Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K924018 | M3 LAG SCREW FIXATION SYSTEM | Osteomed Corp. | 1993-04-01 | Traditional | PDF ↗ |
| K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW | Ace Orthopedic Manufacturing Co. | 1993-03-31 | Traditional | PDF ↗ |
| K923477 | 3.5MM UNIVERSAL COMPRESSION SCREW | Howmedica Corp. | 1993-03-19 | Traditional | PDF ↗ |
| K922788 | BIOACTION LOW PROFILE SCREW SYSTEM | Orthopaedic Biosystems | 1993-03-12 | Traditional | PDF ↗ |
| K915424 | ARTHREX CANNULATED INTERFERENCE SCREW | Arthrex, Inc. | 1993-02-09 | Traditional | PDF ↗ |
| K924514 | ACUFEX FIXATION POST | Acufex Microsurgical, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K923256 | ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW | Alphatec Mfg., Inc. | 1992-10-09 | Traditional | PDF ↗ |
| K922166 | ALPHATEC SMALL FRAGMENT SET | Alphatec Mfg., Inc. | 1992-08-06 | Traditional | PDF ↗ |
| K922322 | ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW | Alphatec Mfg., Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | Concept, Inc. | 1992-05-01 | Traditional | PDF ↗ |
| K915448 | CORTICAL BONE SCREW | Dow Corning Wright | 1992-02-28 | Traditional | PDF ↗ |
| K915316 | AAP BONE SCREW | Aap International, Ltd. | 1992-02-14 | Traditional | PDF ↗ |
| K915613 | BONE SCREW 3.5 MM | Acu Med, Inc. | 1992-02-13 | Traditional | PDF ↗ |
| K915124 | UNIVERSAL COMPRESION SCREW | Howmedica Corp. | 1992-02-11 | Traditional | PDF ↗ |
| K913210 | M. KUROSAKA(TM) FIXATION SCREW | Depuy, Inc. | 1992-01-24 | Traditional | PDF ↗ |
| K910976 | OREGON FIXATION SCREW | Acu Med, Inc. | 1992-01-13 | Traditional | PDF ↗ |
| K915187 | CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW | Techmedica, Inc. | 1991-12-19 | Traditional | PDF ↗ |
| K914004 | ALPHATEC CANNULATED BONE SCREWS | Alphatec Mfg., Inc. | 1991-12-05 | Traditional | PDF ↗ |
| K912598 | ACE CORTICAL BONE SCREW | Ace Medical Co. | 1991-11-27 | Traditional | PDF ↗ |
| K912021 | MAKAR MINI CANNULATED CANCELLOUS SCREWS | Instrument Makar, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K913269 | OSTEO BONE SCREWS | Fred C. Bryson | 1991-11-22 | Traditional | PDF ↗ |
| K913415 | AESCULAP TITANIUM BONE SCREWS | Aesculap, Inc. | 1991-10-29 | Traditional | PDF ↗ |
| K911768 | AMSET(TM) BONE SCREW | Advanced Med/Surg, Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K910193 | HUENE FIXATION SCREW | Acu-Med, Inc. | 1991-08-23 | Traditional | PDF ↗ |
| K904809 | UNIVERSAL COMPRESSION SCREW | Howmedica Corp. | 1991-06-28 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.