The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for 4.0 Mm Arthrex Bio-tendoesis Screw, Model Ar-1540b; 5.5 Mm Arthrex Bio-tenodesis Screw, Models Ar-1555b.
| Device ID | K020043 |
| 510k Number | K020043 |
| Device Name: | 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B |
| 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 | 2002-01-07 |
| Decision Date | 2002-04-02 |
| Summary: | summary |