The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.0mm Titanium (ti.) Locking Screws.
| Device ID | K032559 |
| 510k Number | K032559 |
| Device Name: | SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-19 |
| Decision Date | 2003-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679042040620 | K032559 | 000 |
| H679042040340 | K032559 | 000 |
| H679042040320 | K032559 | 000 |
| H679042040300 | K032559 | 000 |
| H679042040280 | K032559 | 000 |
| H679042040260 | K032559 | 000 |
| H679042040240 | K032559 | 000 |
| H679042040220 | K032559 | 000 |
| H679042040200 | K032559 | 000 |
| H679042040180 | K032559 | 000 |
| H679042040160 | K032559 | 000 |
| H679042040360 | K032559 | 000 |
| H679042040380 | K032559 | 000 |
| H679042040400 | K032559 | 000 |
| H679042040600 | K032559 | 000 |
| H679042040580 | K032559 | 000 |
| H679042040560 | K032559 | 000 |
| H679042040540 | K032559 | 000 |
| H679042040520 | K032559 | 000 |
| H679042040500 | K032559 | 000 |
| H679042040480 | K032559 | 000 |
| H679042040460 | K032559 | 000 |
| H679042040440 | K032559 | 000 |
| H679042040420 | K032559 | 000 |
| H679042040140 | K032559 | 000 |