The following data is part of a premarket notification filed by Rotation Medical, Inc. with the FDA for Collagen Tendon Sheet-ddi (cts-ddi).
| Device ID | K140300 |
| 510k Number | K140300 |
| Device Name: | COLLAGEN TENDON SHEET-DDI (CTS-DDI) |
| Classification | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Applicant | ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 Plymouth, MN 55447 |
| Contact | Jeff Sims |
| Correspondent | Jeff Sims ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 Plymouth, MN 55447 |
| Product Code | OWY |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-06 |
| Decision Date | 2014-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556735664 | K140300 | 000 |
| 00885556735657 | K140300 | 000 |