The following data is part of a premarket notification filed by Coracoid Solutions, Inc. with the FDA for M-fix Acromioclavicular Device.
| Device ID | K153211 |
| 510k Number | K153211 |
| Device Name: | M-Fix Acromioclavicular Device |
| Classification | Washer, Bolt Nut |
| Applicant | CORACOID SOLUTIONS, INC. 15 NORMANS WAY Park City, UT 84060 |
| Contact | Steve Golden |
| Correspondent | Michael Kolber MICHAEL KOLBER 337 ESTER AVE Campbell, CA 94025 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2016-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860366001420 | K153211 | 000 |
| 00860366001413 | K153211 | 000 |