The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.9 Mm Pelvic Screws.
| Device ID | K013044 |
| 510k Number | K013044 |
| Device Name: | SYNTHES 3.9 MM PELVIC SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull 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 | 2001-09-10 |
| Decision Date | 2001-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679SD2111200 | K013044 | 000 |
| H679SD2111150 | K013044 | 000 |
| H679SD2111100 | K013044 | 000 |
| H679SD2111050 | K013044 | 000 |
| H679SD2111000 | K013044 | 000 |
| H679SD2110950 | K013044 | 000 |
| H679SD2110900 | K013044 | 000 |
| H679SD2110850 | K013044 | 000 |
| H679SD2110800 | K013044 | 000 |