The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fracture System.
| Device ID | K112437 |
| 510k Number | K112437 |
| Device Name: | ARTHREX FRACTURE SYSTEM |
| Classification | Washer, Bolt Nut |
| 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 | HTN |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-12-21 |
| Summary: | summary |