The following data is part of a premarket notification filed by Medshape Solutions, Inc with the FDA for Exoshape (tm) Interference Fixation Device Model 1100-00-xxxx (varies By Size).
| Device ID | K111471 |
| 510k Number | K111471 |
| Device Name: | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | MEDSHAPE SOLUTIONS, INC 1575 NORTHSIDE DRIVE NW SUITE 440 Atlanta, GA 30318 |
| Contact | Jack C Griffis, Iii |
| Correspondent | Jack C Griffis, Iii MEDSHAPE SOLUTIONS, INC 1575 NORTHSIDE DRIVE NW 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 | 2011-05-27 |
| Decision Date | 2011-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405986888 | K111471 | 000 |
| 20653405986871 | K111471 | 000 |
| 20653405986864 | K111471 | 000 |
| 20653405986857 | K111471 | 000 |
| 20653405986840 | K111471 | 000 |
| 20653405986833 | K111471 | 000 |
| M970110100123002 | K111471 | 000 |
| M970110000123001 | K111471 | 000 |