Hintermann Series H3 Total Ankle Replacement System
FDA premarket approval P160036/S001 · decided 2019-11-29
Approval details
- PMA number
- P160036
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Hintermann Series H3 Total Ankle Replacement System
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Dt Medtech, LLC
- Date received
- 2019-07-01
- Decision date
- 2019-11-29
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Towson, MD
- Statement
- Approval for the post-approval study protocols for the two post-approval studies.
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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 |