The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Diaphyseal-metaphyseal (dia-meta) Volar Distal Radius Plates.
| Device ID | K070946 |
| 510k Number | K070946 |
| Device Name: | SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-04 |
| Decision Date | 2007-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679041100050 | K070946 | 000 |
| H679041101070 | K070946 | 000 |
| H67904110107S0 | K070946 | 000 |
| H679041101090 | K070946 | 000 |
| H67904110109S0 | K070946 | 000 |
| H679041101110 | K070946 | 000 |
| H67904110111S0 | K070946 | 000 |
| H67904110113S0 | K070946 | 000 |
| H67904110115S0 | K070946 | 000 |
| H67904110105S0 | K070946 | 000 |
| H679041101050 | K070946 | 000 |
| H67904110015S0 | K070946 | 000 |
| H67904110005S0 | K070946 | 000 |
| H679041100070 | K070946 | 000 |
| H67904110007S0 | K070946 | 000 |
| H679041100090 | K070946 | 000 |
| H67904110009S0 | K070946 | 000 |
| H679041100110 | K070946 | 000 |
| H67904110011S0 | K070946 | 000 |
| H67904110013S0 | K070946 | 000 |
| H679021100050 | K070946 | 000 |
| H67902110005S0 | K070946 | 000 |
| H679021101070 | K070946 | 000 |
| H67902110107S0 | K070946 | 000 |
| H679021101090 | K070946 | 000 |
| H67902110109S0 | K070946 | 000 |
| H679021101110 | K070946 | 000 |
| H67902110111S0 | K070946 | 000 |
| H67902110113S0 | K070946 | 000 |
| H679021101150 | K070946 | 000 |
| H67902110105S0 | K070946 | 000 |
| H679021101050 | K070946 | 000 |
| H67902110015S0 | K070946 | 000 |
| H679021100070 | K070946 | 000 |
| H67902110007S0 | K070946 | 000 |
| H679021100090 | K070946 | 000 |
| H67902110009S0 | K070946 | 000 |
| H679021100110 | K070946 | 000 |
| H67902110011S0 | K070946 | 000 |
| H67902110013S0 | K070946 | 000 |
| H679021100150 | K070946 | 000 |
| H67902110115S0 | K070946 | 000 |