The following data is part of a premarket notification filed by Medshape Solutions with the FDA for Wedgeloc 180x Standard Suture Anchor With Opti Fiber Sutures,model 1000-01 Tab Varying Diameters,.
| Device ID | K091202 |
| 510k Number | K091202 |
| Device Name: | WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, |
| 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 | 2009-04-24 |
| Decision Date | 2009-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M97010000425506 | K091202 | 000 |
| M97010000424509 | K091202 | 000 |
| M9701000042350 | K091202 | 000 |
| M97010000335500 | K091202 | 000 |
| M97010000334509 | K091202 | 000 |
| M97010000333508 | K091202 | 000 |
| M97010000325509 | K091202 | 000 |
| M97010000324508 | K091202 | 000 |
| M97010000323507 | K091202 | 000 |