510(k) K982662 ยท HWC Screw, Fixation, Bone
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 28, 1998 |
| Received | Jul 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2003 | Mitek Worldwide Profile 7 x 25 mm Cannulated Interference Screw Round Head
Catalog Number: 230325 Terminated |
None listed | |
| Jul 15, 2003 | Mitek Worldwide Profile 8 x 20 mm Cannulated Interference Screw Round Head
Catalog Number: 230420 Terminated |
None listed | |
| Apr 1, 2003 | Mitek Worldwide Mitek Profile 7 x 25 mm Cannulated Interference Screw Round Head
Product Reference No.: 230325 Terminated |
HWC | None listed |
| Apr 1, 2003 | Mitek Worldwide Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head
Product Reference No.: 230420 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.