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 11 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911398 | ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM | Howmedica Corp. | 1991-06-27 | Traditional | PDF ↗ |
| K905048 | ACE 3.5MM CORTICAL BONE SCREW | Ace Medical Co. | 1991-01-30 | Traditional | PDF ↗ |
| K905358 | CANCELLOUS SCREW | O'Tec Corp. | 1991-01-04 | Traditional | PDF ↗ |
| K905357 | CORTICAL BONE SCREW (EUROPEAN STYLE) | O'Tec Corp. | 1991-01-04 | Traditional | PDF ↗ |
| K905333 | U.S. TYPE CRUCIATE SLOT BONE SCREW | O'Tec Corp. | 1991-01-04 | Traditional | PDF ↗ |
| K903810 | ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW | Ace Medical Co. | 1990-10-16 | Traditional | PDF ↗ |
| K903811 | ACE CANNULATED CORTICAL BONE SCREW | Ace Medical Co. | 1990-10-16 | Traditional | PDF ↗ |
| K901144 | LEVTECH BONE SCREW | Levtech, Inc. | 1990-10-10 | Traditional | PDF ↗ |
| K901814 | MCGRATH ORTHOPAEDIC BONE SCREWS | Mcgrath Surgical , Ltd. | 1990-08-21 | Traditional | PDF ↗ |
| K903255 | CORTICAL BONE SCREW (EUROPEAN STYLE) | Onyx Medical Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K903259 | KNOWLES PIN | Onyx Medical Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K903258 | HAGIE PIN | Onyx Medical Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K903253 | CANCELLOUS SCREW | Onyx Medical Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K903254 | U.S. TYPE CRUCIATE SLOT BONE SCREW | Onyx Medical Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K903244 | LAG SCREW | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K901616 | CANNULATED INTERFERENCE SCREW SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-06-20 | Traditional | PDF ↗ |
| K900132 | ACUFEX STERILE CANNULATED INTERFERENCE SCREW; | Acufex Microsurgical, Inc. | 1990-03-28 | Traditional | PDF ↗ |
| K895711 | ACUFEX INTERFERENCE SCREW, STERILE | Acufex Microsurgical, Inc. | 1990-01-09 | Traditional | PDF ↗ |
| K896601 | EXACTECH BONE SCREW | Exactech, Inc. | 1989-12-06 | Traditional | PDF ↗ |
| K895389 | DEPUY (TM) TRUE COMPRESSION SCREW | Depuy, Inc. | 1989-11-24 | Traditional | PDF ↗ |
| K896044 | CROSS CANCELLOUS BONE SCREW | Buckman Co., Inc. | 1989-11-09 | Traditional | PDF ↗ |
| K895766 | ASNIS II GUIDED BONE SCREW | Howmedica Corp. | 1989-11-08 | Traditional | PDF ↗ |
| K894719 | CYPRESS MEDICAL BONE SCREW & PLATES | Cypress Medical Mfg., Inc. | 1989-10-20 | Traditional | PDF ↗ |
| K895218 | CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM | Orthopedic Systems, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K895219 | CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM | Orthopedic Systems, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K895217 | CORTICAL SCREW | Orthopedic Systems, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K894124 | OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS | Osteonics Corp. | 1989-09-11 | Traditional | PDF ↗ |
| K894830 | CYPRESS CANNULATED BONE SCREW | Cypress Medical Mfg., Inc. | 1989-08-30 | Traditional | PDF ↗ |
| K893512 | DEPUY CANNULATED BONE SCREW | Depuy, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K892925 | VECSEI EXPANDING SCREW | Howmedica Corp. | 1989-08-07 | Traditional | PDF ↗ |
| K892214 | REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW | Ace Medical Co. | 1989-06-22 | Traditional | PDF ↗ |
| K882934 | CASF CANCELLOUS BONE SCREW, BT650 | Terray Manufacturing, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K883910 | ACUFEX INTERFERENCE SCREW AND SCREWDRIVER | Acufex Microsurgical, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K882831 | ACE CANCELLOUS BONE SCREW | Buckman Co., Inc. | 1988-08-01 | Traditional | PDF ↗ |
| K881327 | STUART CANNULATED CANCELLOUS BONE FIXATION SCREW | Stuart Drug & Surgical Supply, Inc. | 1988-05-25 | Traditional | PDF ↗ |
| K874676 | INTERFERENCE SCREW | Concept, Inc. | 1988-03-07 | Traditional | PDF ↗ |
| K875053 | ACROMED CANCELLOUS BONE SCREW | Buckman Co., Inc. | 1988-01-20 | Traditional | PDF ↗ |
| K875050 | ORTHOMET BONE SCREWS | Orthomet, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K874670 | ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW | Buckman Co., Inc. | 1987-12-17 | Traditional | PDF ↗ |
| K874672 | ACE CORTICAL LAG SCREW | Buckman Co., Inc. | 1987-12-11 | Traditional | PDF ↗ |
| K874130 | TITANIUM BONE SCREWS | Orthopedic Systems, Inc. | 1987-12-07 | Traditional | PDF ↗ |
| K874593 | ACE SELFTAPPING CANCELLOUS BONE SCREW | Ace Medical Co. | 1987-11-24 | Traditional | PDF ↗ |
| K873251 | OMNIFIT BONE SCREW | Osteonics Corp. | 1987-09-18 | Traditional | PDF ↗ |
| K872859 | ACE CANCELLOUS BONE SCREW | Ace Medical Co. | 1987-08-17 | Traditional | PDF ↗ |
| K872738 | CORTICAL BONE SCREWS | Military Engineering, Inc. | 1987-07-30 | Traditional | PDF ↗ |
| K872156 | CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM | Concept, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871037 | CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW | Concept, Inc. | 1987-03-25 | Traditional | PDF ↗ |
| K870141 | URESIL T-SYSTEM BONE SCREWS | Uresil Corp. | 1987-02-03 | Traditional | PDF ↗ |
| K864633 | VITALLIUM HEX-DRIVE BONE SCREW SYSTEM | Howmedica Corp. | 1986-12-18 | Traditional | PDF ↗ |
| K864626 | CANCELLOUS BONE SCREW | Dow Corning Wright | 1986-12-15 | Traditional | PDF ↗ |
| K862230 | WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW | Buckman Co., Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K854336 | MONOFIXATEUR | Ortopedia GmbH | 1986-03-05 | Traditional | PDF ↗ |
| K860323 | REESE ARTHRODESIS SCREW | Osteotomy Guide Co. | 1986-02-19 | Traditional | PDF ↗ |
| K860017 | ACROMED CANCELLOUS BONE SCREW | Buckman Co., Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K855031 | MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P | Advanced Biosearch Assn. | 1986-01-21 | Traditional | PDF ↗ |
| K854827 | LINK CORTICAL SCREWS | Link America, Inc. | 1985-12-27 | Traditional | PDF ↗ |
| K854826 | LINK CANCELLOUS SCREWS | Link America, Inc. | 1985-12-27 | Traditional | PDF ↗ |
| K853869 | TITANIUIM BONE SCREW | George Tiemann & Co. | 1985-12-09 | Traditional | PDF ↗ |
| K852026 | FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER | Warsaw Orthopedic, Inc. | 1985-05-22 | Traditional | PDF ↗ |
| K850024 | ORTHOPEDIC IMPLANT SCREWS | Kirkstil Corp., Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K851214 | T-SCREW | Northeast Iowa Podiatry | 1985-04-22 | Traditional | PDF ↗ |
| K850770 | INTERMEDICS BONE SCREW | Intermedics Orthopedics | 1985-04-19 | Traditional | PDF ↗ |
| K831873 | BONE SCREW | W. L. Gore & Associates, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K810497 | BONE FIXACTION SCREW | Serrano Intl. | 1981-03-11 | Traditional | PDF ↗ |
| K810205 | MECRON CANCELLOUS CANNULATED BONE SCREWS | Serrano Intl. | 1981-02-09 | Traditional | PDF ↗ |
| K792205 | SEIDEL INTRAMEDULLARY PLUG | Howmedica Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K792022 | HERBERT BONE SCREW | Zimmer, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K780235 | ORTHOPEDIC DEVICES | Biomet, Inc. | 1978-02-23 | Traditional | PDF ↗ |
| K770035 | SCREW, WADSWORTH OLECRANON | Orthopedic Equipment Co., Inc. | 1977-01-14 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.