510(k) K953653 ยท JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
LUBINUS SP II HIP SYSTEM
| Applicant | Turnkey Intergration USA, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 6, 1995 |
| Received | Aug 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. Open, Classified |
JDG | None listed |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Open, Classified |
JDG | None listed |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Open, Classified |
JDG | None listed |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Open, Classified |
JDG | None listed |
| Mar 14, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Open, Classified |
JDG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.