The following data is part of a premarket notification filed by D3 Dc, Llc /stabilynx, Inc with the FDA for Stabilynx Peek Suture Anchor.
| Device ID | K142643 |
| 510k Number | K142643 |
| Device Name: | Stabilynx PEEK Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | D3 DC, LLC /Stabilynx, Inc 3475-0 Edison Way Menlo Park, CA 94025 |
| Contact | Mike Rosenthal |
| Correspondent | Mike Rosenthal D3 DC, LLC /Stabilynx, Inc 3475-0 Edison Way Menlo Park, CA 94025 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2014-12-15 |
| Summary: | summary |