The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.4mm Va-lcp Two-column Narrow Volar Distal Radius.
| Device ID | K092556 |
| 510k Number | K092556 |
| Device Name: | SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-20 |
| Decision Date | 2009-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679041115200 | K092556 | 000 |
| H67904111551S0 | K092556 | 000 |
| H679042100780 | K092556 | 000 |
| H679042100800 | K092556 | 000 |
| H679042100820 | K092556 | 000 |
| H679042100840 | K092556 | 000 |
| H679042100860 | K092556 | 000 |
| H679042100880 | K092556 | 000 |
| H679042100900 | K092556 | 000 |
| H679042100920 | K092556 | 000 |
| H679042100940 | K092556 | 000 |
| H679042100960 | K092556 | 000 |
| H679042100980 | K092556 | 000 |
| H679041115510 | K092556 | 000 |
| H67904111550S0 | K092556 | 000 |
| H67904111520S0 | K092556 | 000 |
| H679041115210 | K092556 | 000 |
| H67904111521S0 | K092556 | 000 |
| H679041115300 | K092556 | 000 |
| H67904111530S0 | K092556 | 000 |
| H679041115310 | K092556 | 000 |
| H67904111531S0 | K092556 | 000 |
| H679041115400 | K092556 | 000 |
| H67904111540S0 | K092556 | 000 |
| H679041115410 | K092556 | 000 |
| H67904111541S0 | K092556 | 000 |
| H679041115500 | K092556 | 000 |
| H679042101000 | K092556 | 000 |
| H679021115200 | K092556 | 000 |
| H67902111551S0 | K092556 | 000 |
| H679022100780 | K092556 | 000 |
| H679022100800 | K092556 | 000 |
| H679022100820 | K092556 | 000 |
| H679022100840 | K092556 | 000 |
| H679022100860 | K092556 | 000 |
| H679022100880 | K092556 | 000 |
| H679022100900 | K092556 | 000 |
| H679022100920 | K092556 | 000 |
| H679022100940 | K092556 | 000 |
| H679022100960 | K092556 | 000 |
| H679022100980 | K092556 | 000 |
| H679021115510 | K092556 | 000 |
| H67902111550S0 | K092556 | 000 |
| H67902111520S0 | K092556 | 000 |
| H679021115210 | K092556 | 000 |
| H67902111521S0 | K092556 | 000 |
| H679021115300 | K092556 | 000 |
| H67902111530S0 | K092556 | 000 |
| H679021115310 | K092556 | 000 |
| H67902111531S0 | K092556 | 000 |
| H679021115400 | K092556 | 000 |
| H67902111540S0 | K092556 | 000 |
| H679021115410 | K092556 | 000 |
| H67902111541S0 | K092556 | 000 |
| H679021115500 | K092556 | 000 |
| H6790221010000 | K092556 | 000 |