The following data is part of a premarket notification filed by Medshape Solutions with the FDA for Wedgeloc 180x (standard) And (cortical) Suture Anchor With Opti-fiber Sutures.
| Device ID | K092914 |
| 510k Number | K092914 |
| Device Name: | WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2009-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M97010000412506 | K092914 | 000 |
| M97010000322506 | K092914 | 000 |