The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5mm Cortex Screws.
| Device ID | K043185 |
| 510k Number | K043185 |
| Device Name: | SYNTHES 3.5MM CORTEX 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 | 2004-11-17 |
| Decision Date | 2005-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679042000100 | K043185 | 000 |
| H679042000450 | K043185 | 000 |
| H679042000460 | K043185 | 000 |
| H679042000480 | K043185 | 000 |
| H679042000500 | K043185 | 000 |
| H679042000550 | K043185 | 000 |
| H679042000600 | K043185 | 000 |
| H679022000100 | K043185 | 000 |
| H679022000120 | K043185 | 000 |
| H679022000140 | K043185 | 000 |
| H679022000160 | K043185 | 000 |
| H679022000180 | K043185 | 000 |
| H679022000200 | K043185 | 000 |
| H679022000220 | K043185 | 000 |
| H679022000240 | K043185 | 000 |
| H679042000440 | K043185 | 000 |
| H679042000420 | K043185 | 000 |
| H679042000400 | K043185 | 000 |
| H679042000120 | K043185 | 000 |
| H679042000140 | K043185 | 000 |
| H679042000160 | K043185 | 000 |
| H679042000180 | K043185 | 000 |
| H679042000200 | K043185 | 000 |
| H679042000220 | K043185 | 000 |
| H679042000240 | K043185 | 000 |
| H679042000260 | K043185 | 000 |
| H679042000280 | K043185 | 000 |
| H679042000300 | K043185 | 000 |
| H679042000320 | K043185 | 000 |
| H679042000340 | K043185 | 000 |
| H679042000360 | K043185 | 000 |
| H679042000380 | K043185 | 000 |
| H679022000260 | K043185 | 000 |
| H679022000280 | K043185 | 000 |
| H679022000800 | K043185 | 000 |
| H679022000850 | K043185 | 000 |
| H679022000900 | K043185 | 000 |
| H679022000950 | K043185 | 000 |
| H679022001000 | K043185 | 000 |
| H679022001050 | K043185 | 000 |
| H679022001100 | K043185 | 000 |
| H679022001150 | K043185 | 000 |
| H679022001200 | K043185 | 000 |
| H679022001250 | K043185 | 000 |
| H679022001300 | K043185 | 000 |
| H679022001350 | K043185 | 000 |
| H679022001400 | K043185 | 000 |
| H679022001450 | K043185 | 000 |
| H679022000750 | K043185 | 000 |
| H679022000700 | K043185 | 000 |
| H679022000650 | K043185 | 000 |
| H679022000300 | K043185 | 000 |
| H679022000320 | K043185 | 000 |
| H679022000340 | K043185 | 000 |
| H679022000360 | K043185 | 000 |
| H679022000380 | K043185 | 000 |
| H679022000400 | K043185 | 000 |
| H679022000420 | K043185 | 000 |
| H679022000440 | K043185 | 000 |
| H679022000450 | K043185 | 000 |
| H679022000460 | K043185 | 000 |
| H679022000480 | K043185 | 000 |
| H679022000500 | K043185 | 000 |
| H679022000550 | K043185 | 000 |
| H679022000600 | K043185 | 000 |
| H679022001500 | K043185 | 000 |