The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To:synthes (usa) Titanium Wire.
| Device ID | K042606 |
| 510k Number | K042606 |
| Device Name: | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-24 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587056210 | K042606 | 000 |
| H98049310401S0 | K042606 | 000 |