The following data is part of a premarket notification filed by Medshape, Inc with the FDA for Exoshape Duo Soft Tissue Fastener.
| Device ID | K132783 |
| 510k Number | K132783 |
| Device Name: | EXOSHAPE DUO SOFT TISSUE FASTENER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | MEDSHAPE, INC 1575 NORTHSIDE DRIVE NW SUITE 440 Atlanta, GA 30318 |
| Contact | Stephen Laffoon |
| Correspondent | Stephen Laffoon MEDSHAPE, INC 1575 NORTHSIDE DRIVE NW SUITE 440 Atlanta, GA 30318 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2013-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854082161 | K132783 | 000 |
| 30845854082151 | K132783 | 000 |
| 30845854082144 | K132783 | 000 |
| 30845854082137 | K132783 | 000 |
| M97016000001102 | K132783 | 000 |
| M97016000001001 | K132783 | 000 |
| M97016000000909 | K132783 | 000 |
| M97016000000808 | K132783 | 000 |