The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.0mm Headless Compression Screws.
| Device ID | K050636 |
| 510k Number | K050636 |
| Device Name: | SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-11 |
| Decision Date | 2005-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679022261400 | K050636 | 000 |
| H679022261220 | K050636 | 000 |
| H679022261210 | K050636 | 000 |
| H679022261200 | K050636 | 000 |
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