The following data is part of a premarket notification filed by Ensemble Orthopedics, Llc with the FDA for Ensemble Cmc, Size 141, Ensemble Cmc, Size 151, Ensemble Cmc, Size 161.
| Device ID | K201072 |
| 510k Number | K201072 |
| Device Name: | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | Ensemble Orthopedics, LLC 107 Redbud Trail, Suite 11 Austin, TX 78746 |
| Contact | Sandie Roth |
| Correspondent | Sandie Roth Ensemble Orthopedics, LLC 107 Redbud Trail, Suite 11 Austin, TX 78746 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-22 |
| Decision Date | 2020-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810063560096 | K201072 | 000 |
| 00810063560089 | K201072 | 000 |
| 00810063560003 | K201072 | 000 |
| 00810063560010 | K201072 | 000 |
| 00810063560027 | K201072 | 000 |
| 00810063560034 | K201072 | 000 |
| 00810063560041 | K201072 | 000 |
| 00810063560058 | K201072 | 000 |
| 00810063560065 | K201072 | 000 |
| 00810063560072 | K201072 | 000 |
| 00810063560201 | K201072 | 000 |