The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for G-force Tenodesis Screw.
| Device ID | K083150 |
| 510k Number | K083150 |
| Device Name: | G-FORCE TENODESIS SCREW |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-24 |
| Decision Date | 2009-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420115393 | K083150 | 000 |
| 00840420115386 | K083150 | 000 |
| 00840420115379 | K083150 | 000 |
| 00840420115362 | K083150 | 000 |
| 00840420115355 | K083150 | 000 |
| 00840420115348 | K083150 | 000 |
| 00840420115331 | K083150 | 000 |
| 00840420115324 | K083150 | 000 |