Hintermann Series H3 Total Ankle Replacement System
FDA premarket approval P160036/S002 · decided 2021-03-11
Approval details
- PMA number
- P160036
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hintermann Series H3 Total Ankle Replacement System
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Applicant
- Dt Medtech, LLC
- Date received
- 2021-02-26
- Decision date
- 2021-03-11
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- NTG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Towson, MD
- Statement
- Introduction of a new robotic system at Marle Orthopaedics SAS (approved supplier of DT MedTech). The new robotic system will replace the existing robotic system which is used to manufacture components for the Hintermann Series H3 Total Ankle Replacement System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hintermann Series H2 Total Ankle System (K171004) | Dt Medtech, LLC | 2017-11-07 |