The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Tibial Graftbolt.
| Device ID | K103060 |
| 510k Number | K103060 |
| Device Name: | ARTHREX TIBIAL GRAFTBOLT |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-18 |
| Decision Date | 2011-01-05 |
| Summary: | summary |