The following data is part of a premarket notification filed by Medshape Solutions with the FDA for Wedgeloc Suture Anchor With Opti-fiber Sutures, Model 1000-01-055.
| Device ID | K083792 |
| 510k Number | K083792 |
| Device Name: | WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. SUITE 440 Atlanta, GA 30318 |
| Contact | Jack Griffis |
| Correspondent | Jack Griffis MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. SUITE 440 Atlanta, GA 30318 |
| Product Code | HWC |
| Subsequent Product Code | GAT |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-19 |
| Decision Date | 2009-03-25 |
| Summary: | summary |