The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio-compression Screw, Small, Arthrex Bio-compression Screw, Large, Models Ar-5024b, Ar-5025b.
| Device ID | K032098 |
| 510k Number | K032098 |
| Device Name: | ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse 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 | 2003-07-08 |
| Decision Date | 2003-10-07 |
| Summary: | summary |