The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for G-force Gen 2 Suture Anchor System.
| Device ID | K141011 |
| 510k Number | K141011 |
| Device Name: | G-FORCE GEN 2 SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Dmitri Falkner |
| Correspondent | Dmitri Falkner WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420165961 | K141011 | 000 |
| 00840420165954 | K141011 | 000 |
| 00840420165947 | K141011 | 000 |