Hintermann Series H3 Total Ankle Replacement System
FDA premarket approval P160036/S004 · decided 2023-11-06
Approval details
- PMA number
- P160036
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Hintermann Series H3 Total Ankle Replacement System
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Dt Medtech, LLC
- Date received
- 2023-05-08
- Decision date
- 2023-11-06
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Towson, MD
- Statement
- Approval to introduce patient specific instrumentation (i.e., OPTIX Patient Specific Instruments (PSI)) to the Hintermann Series H3 Total Ankle Replacement System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hintermann Series H2 Total Ankle System (K171004) | Dt Medtech, LLC | 2017-11-07 |