The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.4 Mm Va-lcp Two Column Volar Distal Radius Plates.
| Device ID | K083694 |
| 510k Number | K083694 |
| Device Name: | SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Sheri L Musgung |
| Correspondent | Sheri L Musgung 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 | 2008-12-12 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679041116200 | K083694 | 000 |
| H67904111720S0 | K083694 | 000 |
| H679041117210 | K083694 | 000 |
| H67904111721S0 | K083694 | 000 |
| H679041117300 | K083694 | 000 |
| H67904111730S0 | K083694 | 000 |
| H679041117310 | K083694 | 000 |
| H67904111731S0 | K083694 | 000 |
| H679041117400 | K083694 | 000 |
| H67904111740S0 | K083694 | 000 |
| H679041117410 | K083694 | 000 |
| H67904111741S0 | K083694 | 000 |
| H679041117500 | K083694 | 000 |
| H67904111750S0 | K083694 | 000 |
| H679041117510 | K083694 | 000 |
| H679041117200 | K083694 | 000 |
| H67904111651S0 | K083694 | 000 |
| H67904111620S0 | K083694 | 000 |
| H679041116210 | K083694 | 000 |
| H67904111621S0 | K083694 | 000 |
| H679041116300 | K083694 | 000 |
| H67904111630S0 | K083694 | 000 |
| H679041116310 | K083694 | 000 |
| H67904111631S0 | K083694 | 000 |
| H679041116400 | K083694 | 000 |
| H67904111640S0 | K083694 | 000 |
| H679041116410 | K083694 | 000 |
| H67904111641S0 | K083694 | 000 |
| H679041116500 | K083694 | 000 |
| H67904111650S0 | K083694 | 000 |
| H679041116510 | K083694 | 000 |
| H67904111751S0 | K083694 | 000 |
| H679021116200 | K083694 | 000 |
| H67902111720S0 | K083694 | 000 |
| H679021117210 | K083694 | 000 |
| H67902111721S0 | K083694 | 000 |
| H679021117300 | K083694 | 000 |
| H67902111730S0 | K083694 | 000 |
| H679021117310 | K083694 | 000 |
| H67902111731S0 | K083694 | 000 |
| H679021117400 | K083694 | 000 |
| H67902111740S0 | K083694 | 000 |
| H679021117410 | K083694 | 000 |
| H67902111741S0 | K083694 | 000 |
| H679021117500 | K083694 | 000 |
| H67902111750S0 | K083694 | 000 |
| H679021117510 | K083694 | 000 |
| H679021117200 | K083694 | 000 |
| H67902111651S0 | K083694 | 000 |
| H67902111620S0 | K083694 | 000 |
| H679021116210 | K083694 | 000 |
| H67902111621S0 | K083694 | 000 |
| H679021116300 | K083694 | 000 |
| H67902111630S0 | K083694 | 000 |
| H679021116310 | K083694 | 000 |
| H67902111631S0 | K083694 | 000 |
| H679021116400 | K083694 | 000 |
| H67902111640S0 | K083694 | 000 |
| H679021116410 | K083694 | 000 |
| H67902111641S0 | K083694 | 000 |
| H679021116500 | K083694 | 000 |
| H67902111650S0 | K083694 | 000 |
| H679021116510 | K083694 | 000 |
| H67902111751S0 | K083694 | 000 |