The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fibertape (tm), 2mm, Arthrex Fibertape (tm), 3mm, Arthrex Fibertape (tm), 4mm, Models Ar-7237, Ar-7238, Ar-7239.
| Device ID | K032245 |
| 510k Number | K032245 |
| Device Name: | ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-22 |
| Decision Date | 2004-01-14 |
| Summary: | summary |