The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bioabsorbable Interference Screw.
| Device ID | K945303 |
| 510k Number | K945303 |
| Device Name: | ARTHREX BIOABSORBABLE INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Contact | Ken Durbin |
| Correspondent | Ken Durbin ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1996-01-25 |