EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S008 · decided 2012-08-17
Approval details
- PMA number
- P050039
- Supplement
- S008
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2012-03-26
- Decision date
- 2012-08-17
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR REQUESTED CHANGES TO THE BLEND/POLISH WORK INSTRUCTION FOR THE NOVACTION SPLINED STEMS.
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510(k) clearances by this applicant
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|---|---|---|
| Equinoxe® Shoulder System (K260583) | Exactech, Inc. | 2026-04-14 |
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| Alteon® HA Femoral Stems (K243839) | Exactech, Inc. | 2025-03-10 |
| Exactech® TRULIANT® Knee System (K240393) | Exactech, Inc. | 2024-10-03 |
| Equinoxe® Central Screw Baseplate System (K233482) | Exactech, Inc. | 2024-07-18 |
| Exactech® Vantage® Total Ankle System (K230717) | Exactech, Inc. | 2023-10-12 |