The following data is part of a premarket notification filed by Ascension Orthopedic with the FDA for Ascension Nugrip Cmc Implant.
| Device ID | K112278 |
| 510k Number | K112278 |
| Device Name: | ASCENSION NUGRIP CMC IMPLANT |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Contact | Bradley W Strasser |
| Correspondent | Bradley W Strasser ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-09 |
| Decision Date | 2011-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269TRL44340M1 | K112278 | 000 |
| 00885556857984 | K112278 | 000 |
| 00885556857977 | K112278 | 000 |
| 00885556857960 | K112278 | 000 |
| 00885556857953 | K112278 | 000 |
| 00885556857946 | K112278 | 000 |
| 00885556857939 | K112278 | 000 |
| 00885556857922 | K112278 | 000 |
| 00885556857915 | K112278 | 000 |
| 00885556857823 | K112278 | 000 |
| 00885556857816 | K112278 | 000 |
| 00885556857809 | K112278 | 000 |
| 00885556857793 | K112278 | 000 |
| 00885556857786 | K112278 | 000 |
| 00885556857779 | K112278 | 000 |
| 00885556857762 | K112278 | 000 |
| 00885556857755 | K112278 | 000 |
| 00885556857991 | K112278 | 000 |
| M268NUGRIPINSTP1 | K112278 | 000 |
| 10381780120056 | K112278 | 000 |
| M269TRL44340L1 | K112278 | 000 |
| M269TRL44330S1 | K112278 | 000 |
| M269TRL44330M1 | K112278 | 000 |
| M269TRL44330L1 | K112278 | 000 |
| M269TRL44320S1 | K112278 | 000 |
| M269TRL44320M1 | K112278 | 000 |
| M269TRL44310S1 | K112278 | 000 |
| M269TRL44310M1 | K112278 | 000 |
| 10381780120131 | K112278 | 000 |
| 10381780120124 | K112278 | 000 |
| 10381780120117 | K112278 | 000 |
| 10381780120100 | K112278 | 000 |
| 10381780120094 | K112278 | 000 |
| 10381780120087 | K112278 | 000 |
| 10381780120070 | K112278 | 000 |
| 10381780120063 | K112278 | 000 |
| 00885556857748 | K112278 | 000 |