The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Stablyx Cmc Arthroplasty Implant Model Sizes 1, 2, 3, 4, And 5.
| Device ID | K111068 |
| 510k Number | K111068 |
| Device Name: | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Contact | Ana M Escagedo, Esq |
| Correspondent | Ana M Escagedo, Esq SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-12-30 |
| Summary: | summary |