The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Staples.
| Device ID | K943492 |
| 510k Number | K943492 |
| Device Name: | ARTHREX STAPLES |
| Classification | Staple, Fixation, Bone |
| Applicant | ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Contact | Leonard E Baltz |
| Correspondent | Leonard E Baltz ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1995-02-01 |