The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 1.5mm Headless Compression Screws.
| Device ID | K090949 |
| 510k Number | K090949 |
| Device Name: | SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger SYNTHES (USA) 1301 GOSHEN PKWY. 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 | 2009-04-03 |
| Decision Date | 2009-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902230116S0 | K090949 | 000 |
| H679022301150 | K090949 | 000 |
| H67902230115S0 | K090949 | 000 |
| H679022301160 | K090949 | 000 |
| H679022301170 | K090949 | 000 |
| H67902230117S0 | K090949 | 000 |
| H679022301180 | K090949 | 000 |
| H67902230118S0 | K090949 | 000 |
| H679022301190 | K090949 | 000 |
| H67902230119S0 | K090949 | 000 |
| H679022301200 | K090949 | 000 |
| H67902230114S0 | K090949 | 000 |
| H679022301140 | K090949 | 000 |
| H679022301090 | K090949 | 000 |
| H67902230109S0 | K090949 | 000 |
| H679022301100 | K090949 | 000 |
| H67902230110S0 | K090949 | 000 |
| H679022301110 | K090949 | 000 |
| H67902230111S0 | K090949 | 000 |
| H679022301120 | K090949 | 000 |
| H67902230112S0 | K090949 | 000 |
| H679022301130 | K090949 | 000 |
| H67902230113S0 | K090949 | 000 |
| H67902230120S0 | K090949 | 000 |
| H679042301090 | K090949 | 000 |
| H67904230115S0 | K090949 | 000 |
| H679042301160 | K090949 | 000 |
| H67904230116S0 | K090949 | 000 |
| H679042301170 | K090949 | 000 |
| H67904230117S0 | K090949 | 000 |
| H679042301180 | K090949 | 000 |
| H67904230118S0 | K090949 | 000 |
| H679042301190 | K090949 | 000 |
| H67904230119S0 | K090949 | 000 |
| H679042301200 | K090949 | 000 |
| H679042301150 | K090949 | 000 |
| H67904230114S0 | K090949 | 000 |
| H67904230109S0 | K090949 | 000 |
| H679042301100 | K090949 | 000 |
| H67904230110S0 | K090949 | 000 |
| H679042301110 | K090949 | 000 |
| H67904230111S0 | K090949 | 000 |
| H679042301120 | K090949 | 000 |
| H67904230112S0 | K090949 | 000 |
| H679042301130 | K090949 | 000 |
| H67904230113S0 | K090949 | 000 |
| H679042301140 | K090949 | 000 |
| H67904230120S0 | K090949 | 000 |