The following data is part of a premarket notification filed by Extremity Medical Llc with the FDA for Extremity Medical Suture Anchor.
| Device ID | K083151 |
| 510k Number | K083151 |
| Device Name: | EXTREMITY MEDICAL SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Contact | Jamy Gannoe |
| Correspondent | Jamy Gannoe EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-24 |
| Decision Date | 2009-01-22 |
| Summary: | summary |