The following data is part of a premarket notification filed by Medshape, Inc with the FDA for Eclipse Soft Tissue Fastener.
| Device ID | K123350 |
| 510k Number | K123350 |
| Device Name: | ECLIPSE SOFT TISSUE FASTENER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | MEDSHAPE, INC 1575 NORTHSIDE DRIVE, SUITE 440 Atlanta, GA 30318 |
| Contact | Jack C Griffis Iii |
| Correspondent | Jack C Griffis Iii MEDSHAPE, INC 1575 NORTHSIDE DRIVE, 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 | 2012-10-31 |
| Decision Date | 2013-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M970150000092000 | K123350 | 000 |
| M970150000041700 | K123350 | 000 |
| M970150000051207 | K123350 | 000 |
| M970150000052006 | K123350 | 000 |
| M970150000061208 | K123350 | 000 |
| M970150000062007 | K123350 | 000 |
| M970150000071209 | K123350 | 000 |
| M970150000072008 | K123350 | 000 |
| M970150000081200 | K123350 | 000 |
| M970150000082009 | K123350 | 000 |
| M970150000091500 | K123350 | 000 |
| M970150000041004 | K123350 | 000 |