This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
The 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
| Device | 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 |
| PMA | P160036 |
| Supplement | S002 |
| Product Code | NTG |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DT MedTech LLC 110 West Road suite 227 towson, MD 21204 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160036 | Original Filing | |
| S003 | 2021-09-10 | Normal 180 Day Track No User Fee |
| S002 | 2021-02-26 | 30-day Notice |
| S001 | 2019-07-01 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| B095300205 | P160036 | 000 |
| B095302203 | P160036 | 000 |
| B095302204 | P160036 | 000 |
| B095302205 | P160036 | 000 |
| B095302206 | P160036 | 000 |
| B0953300105 | P160036 | 000 |
| B0953300106 | P160036 | 000 |
| B0953300107 | P160036 | 000 |
| B0953300109 | P160036 | 000 |
| B0953300205 | P160036 | 000 |
| B0953300206 | P160036 | 000 |
| B0953300207 | P160036 | 000 |
| B0953300209 | P160036 | 000 |
| B0953300305 | P160036 | 000 |
| B0953300306 | P160036 | 000 |
| B0953300307 | P160036 | 000 |
| B0953300309 | P160036 | 000 |
| B0953300405 | P160036 | 000 |
| B095302202 | P160036 | 000 |
| B095302201 | P160036 | 000 |
| B095300206 | P160036 | 000 |
| B095300207 | P160036 | 000 |
| B095300305 | P160036 | 000 |
| B095300306 | P160036 | 000 |
| B095300307 | P160036 | 000 |
| B095300309 | P160036 | 000 |
| B095300406 | P160036 | 000 |
| B095300407 | P160036 | 000 |
| B095300409 | P160036 | 000 |
| B095300505 | P160036 | 000 |
| B095300506 | P160036 | 000 |
| B095300507 | P160036 | 000 |
| B095300509 | P160036 | 000 |
| B095300605 | P160036 | 000 |
| B095300606 | P160036 | 000 |
| B095300607 | P160036 | 000 |
| B095300609 | P160036 | 000 |
| B0953300406 | P160036 | 000 |
| B0953300407 | P160036 | 000 |
| B0953301125 | P160036 | 000 |
| B0953302111 | P160036 | 000 |
| B0953302112 | P160036 | 000 |
| B0953302113 | P160036 | 000 |
| B0953302114 | P160036 | 000 |
| B0953302115 | P160036 | 000 |
| B0953302116 | P160036 | 000 |
| B0953302121 | P160036 | 000 |
| B0953302122 | P160036 | 000 |
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| B0953301124 | P160036 | 000 |
| B0953301123 | P160036 | 000 |
| B0953300409 | P160036 | 000 |
| B0953300505 | P160036 | 000 |
| B0953300506 | P160036 | 000 |
| B0953300507 | P160036 | 000 |
| B0953300509 | P160036 | 000 |
| B0953300605 | P160036 | 000 |
| B0953300606 | P160036 | 000 |
| B0953300607 | P160036 | 000 |
| B0953300609 | P160036 | 000 |
| B0953301111 | P160036 | 000 |
| B0953301112 | P160036 | 000 |
| B0953301113 | P160036 | 000 |
| B0953301114 | P160036 | 000 |
| B0953301115 | P160036 | 000 |
| B0953301116 | P160036 | 000 |
| B0953301121 | P160036 | 000 |
| B0953301122 | P160036 | 000 |
| B0953302206 | P160036 | 000 |