The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Humeral Fracture Plates And Screws.
| Device ID | K041965 |
| 510k Number | K041965 |
| Device Name: | ARTHREX HUMERAL FRACTURE PLATES AND SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Sally Foust |
| Correspondent | Sally Foust ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-21 |
| Decision Date | 2004-09-08 |
| Summary: | summary |