C2-A TAPER ACETABULAR SYSTEM
FDA premarket approval P050009/S005 · decided 2007-11-30
Approval details
- PMA number
- P050009
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- C2-A TAPER ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Biomet, Inc.
- Date received
- 2007-11-02
- Decision date
- 2007-11-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- CHANGE BY THE SUPPLIER TO IMPLEMENT NEW SOFTWARE ON THE MANUFACTURING LINE.
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510(k) clearances by this applicant
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|---|---|---|
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| StageOne™ Select Hip Cement Spacer Molds (K222760) | Biomet, Inc. | 2022-12-28 |
| StageOne™ Shoulder Cement Spacer Molds (K221968) | Biomet, Inc. | 2022-09-15 |
| StageOne Knee Cement Spacer Molds (K213287) | Biomet, Inc. | 2022-09-02 |
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| Comprehensive Humeral Fracture Positioning Sleeves (K212435) | Biomet, Inc. | 2021-12-10 |