The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 7.3 Mm Cannulated Slipped Capital Femoral Epiphysis Screws (scfe).
| Device ID | K092909 |
| 510k Number | K092909 |
| Device Name: | SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung 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 | 2009-09-22 |
| Decision Date | 2010-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679022076370 | K092909 | 000 |
| H679022076170 | K092909 | 000 |
| H679022076160 | K092909 | 000 |
| H679022076150 | K092909 | 000 |
| H679022076140 | K092909 | 000 |
| H679022076130 | K092909 | 000 |
| H679022076120 | K092909 | 000 |
| H679022076110 | K092909 | 000 |
| H679022076100 | K092909 | 000 |
| H679022076090 | K092909 | 000 |
| H679022076080 | K092909 | 000 |
| H679022076070 | K092909 | 000 |
| H679022076060 | K092909 | 000 |
| H679022076050 | K092909 | 000 |
| H679022076040 | K092909 | 000 |
| H679022076030 | K092909 | 000 |
| H679022076020 | K092909 | 000 |
| H679022076010 | K092909 | 000 |
| H679022076180 | K092909 | 000 |
| H679022076190 | K092909 | 000 |
| H679022076360 | K092909 | 000 |
| H679022076350 | K092909 | 000 |
| H679022076340 | K092909 | 000 |
| H679022076330 | K092909 | 000 |
| H679022076320 | K092909 | 000 |
| H679022076310 | K092909 | 000 |
| H679022076300 | K092909 | 000 |
| H679022076290 | K092909 | 000 |
| H679022076280 | K092909 | 000 |
| H679022076270 | K092909 | 000 |
| H679022076260 | K092909 | 000 |
| H679022076250 | K092909 | 000 |
| H679022076240 | K092909 | 000 |
| H679022076230 | K092909 | 000 |
| H679022076220 | K092909 | 000 |
| H679022076210 | K092909 | 000 |
| H679022076200 | K092909 | 000 |
| H679022076000 | K092909 | 000 |