510(k) K894403 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent for Some Indications, Feb 2, 1990 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS LFT
Intended for knee replacement
Product Number: 6728-2-609 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS LFT
Intended for knee replacement
Product Number: 6728-2-611 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS RT
Intended for knee replacement
Product Number: 6728-2-709 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS RT
Intended for knee replacement
Product Number: 6728-2-711 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.