The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for G-force Ti Suture Anchor System.
| Device ID | K100579 |
| 510k Number | K100579 |
| Device Name: | G-FORCE TI SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Kellen Hills |
| Correspondent | Kellen Hills WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420142771 | K100579 | 000 |
| 00840420142764 | K100579 | 000 |
| 00840420142757 | K100579 | 000 |