510(k) K181280 ยท KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Patello-Femoral Wave (Kahuna) Arthroplasty System
| Applicant | Arthrosurface, Inc., Franklin MA, US |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | May 15, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181280
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 Open, Classified |
KRR | None listed |
| Feb 1, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008 Open, Classified |
KRR | None listed |
| Feb 1, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 Open, Classified |
KRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.