The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Titanium Wire.
| Device ID | K041333 |
| 510k Number | K041333 |
| Device Name: | SYNTHES (USA) TITANIUM WIRE |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-19 |
| Decision Date | 2004-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98049310301S0 | K041333 | 000 |
| H98049310201S0 | K041333 | 000 |
| H98049310101S0 | K041333 | 000 |
| 10887587056166 | K041333 | 000 |