The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Tenodesis Screw 7mm, 8mm, 9mm.
| Device ID | K010525 |
| 510k Number | K010525 |
| Device Name: | ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Vernon Brown |
| Correspondent | Vernon Brown ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-05-23 |
| Summary: | summary |