LUBINUS SP II HIP SYSTEM
FDA 510(k) clearance K953653 · decided 1995-11-06
Clearance details
- K-number
- K953653
- Device name
- LUBINUS SP II HIP SYSTEM
- Applicant
- Turnkey Intergration USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-03
- Decision date
- 1995-11-06
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- JDG
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| INTEGRAL CO-CR FEMORAL COMPONENT (K942479) | Biomet, Inc. | 1994-09-20 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. recall (Z-2288-2025) | Waldemar Link GmbH & Co. KG (Mfg Site) | 2025-08-11 |
| SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented recall (Z-1296-2024) | Waldemar Link GmbH & Co. KG (Mfg Site) | 2024-03-14 |
| SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented recall (Z-1297-2024) | Waldemar Link GmbH & Co. KG (Mfg Site) | 2024-03-14 |
| SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented recall (Z-1298-2024) | Waldemar Link GmbH & Co. KG (Mfg Site) | 2024-03-14 |
| SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented recall (Z-1299-2024) | Waldemar Link GmbH & Co. KG (Mfg Site) | 2024-03-14 |