The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Gravitytm Peek-optima Suture Anchor.
| Device ID | K170265 |
| 510k Number | K170265 |
| Device Name: | GRAVITYTM PEEK-OPTIMA Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420193735 | K170265 | 000 |
| 00840420193728 | K170265 | 000 |
| 00840420193711 | K170265 | 000 |