The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.4 Mm Titanium (ti.) Locking Screws.
| Device ID | K033975 |
| 510k Number | K033975 |
| Device Name: | SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804976840 | K033975 | 000 |
| H9804976820 | K033975 | 000 |
| H9804976800 | K033975 | 000 |
| H9804976780 | K033975 | 000 |
| H9804976760 | K033975 | 000 |
| H9804976740 | K033975 | 000 |
| H9804976720 | K033975 | 000 |
| H9804976700 | K033975 | 000 |
| H9804976680 | K033975 | 000 |