The following data is part of a premarket notification filed by Medshape, Inc with the FDA for Porous Morphix Suture Anchor With Force Fiber Suture.
| Device ID | K130467 |
| 510k Number | K130467 |
| Device Name: | POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | MEDSHAPE, INC 1575 NORTHSIDE DRIVE NW SUITE 440 Atlanta, GA 30318 |
| Contact | Kenneth M Dupont, Ph.d. |
| Correspondent | Kenneth M Dupont, Ph.d. 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 | 2013-02-25 |
| Decision Date | 2013-12-05 |
| Summary: | summary |