The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Titanium And Bio-degradable (polymer) Implants.
| Device ID | K053338 |
| 510k Number | K053338 |
| Device Name: | ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HWC |
| Subsequent Product Code | MAI |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-01 |
| Decision Date | 2006-01-26 |
| Summary: | summary |