The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 2.4mm Va-lcp Dorsal Distal Radius Plates.
| Device ID | K102694 |
| 510k Number | K102694 |
| Device Name: | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Christopher Hack, Esq |
| Correspondent | Christopher Hack, Esq 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 | 2010-09-20 |
| Decision Date | 2010-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679041151300 | K102694 | 000 |
| H679041155300 | K102694 | 000 |
| H67904115451S0 | K102694 | 000 |
| H679041154510 | K102694 | 000 |
| H67904115450S0 | K102694 | 000 |
| H679041154500 | K102694 | 000 |
| H67904115431S0 | K102694 | 000 |
| H679041154310 | K102694 | 000 |
| H67904115430S0 | K102694 | 000 |
| H67904115530S0 | K102694 | 000 |
| H679041155400 | K102694 | 000 |
| H679041156410 | K102694 | 000 |
| H67904115640S0 | K102694 | 000 |
| H679041156400 | K102694 | 000 |
| H67904115631S0 | K102694 | 000 |
| H679041156310 | K102694 | 000 |
| H67904115630S0 | K102694 | 000 |
| H679041156300 | K102694 | 000 |
| H67904115540S0 | K102694 | 000 |
| H679041154300 | K102694 | 000 |
| H67904115350S0 | K102694 | 000 |
| H679041152300 | K102694 | 000 |
| H67904115151S0 | K102694 | 000 |
| H679041151510 | K102694 | 000 |
| H67904115150S0 | K102694 | 000 |
| H679041151500 | K102694 | 000 |
| H67904115131S0 | K102694 | 000 |
| H679041151310 | K102694 | 000 |
| H67904115130S0 | K102694 | 000 |
| H67904115230S0 | K102694 | 000 |
| H679041152310 | K102694 | 000 |
| H679041153500 | K102694 | 000 |
| H67904115330S0 | K102694 | 000 |
| H679041153300 | K102694 | 000 |
| H67904115251S0 | K102694 | 000 |
| H679041152510 | K102694 | 000 |
| H67904115250S0 | K102694 | 000 |
| H679041152500 | K102694 | 000 |
| H67904115231S0 | K102694 | 000 |
| H67904115641S0 | K102694 | 000 |
| H679021151300 | K102694 | 000 |
| H679021155300 | K102694 | 000 |
| H67902115451S0 | K102694 | 000 |
| H679021154510 | K102694 | 000 |
| H67902115450S0 | K102694 | 000 |
| H679021154500 | K102694 | 000 |
| H67902115431S0 | K102694 | 000 |
| H679021154310 | K102694 | 000 |
| H67902115430S0 | K102694 | 000 |
| H67902115530S0 | K102694 | 000 |
| H679021155400 | K102694 | 000 |
| H679021156410 | K102694 | 000 |
| H67902115640S0 | K102694 | 000 |
| H679021156400 | K102694 | 000 |
| H67902115631S0 | K102694 | 000 |
| H679021156310 | K102694 | 000 |
| H67902115630S0 | K102694 | 000 |
| H679021156300 | K102694 | 000 |
| H67902115540S0 | K102694 | 000 |
| H679021154300 | K102694 | 000 |
| H67902115350S0 | K102694 | 000 |
| H679021152300 | K102694 | 000 |
| H67902115151S0 | K102694 | 000 |
| H679021151510 | K102694 | 000 |
| H67902115150S0 | K102694 | 000 |
| H679021151500 | K102694 | 000 |
| H67902115131S0 | K102694 | 000 |
| H679021151310 | K102694 | 000 |
| H67902115130S0 | K102694 | 000 |
| H67902115230S0 | K102694 | 000 |
| H679021152310 | K102694 | 000 |
| H679021153500 | K102694 | 000 |
| H67902115330S0 | K102694 | 000 |
| H679021153300 | K102694 | 000 |
| H67902115251S0 | K102694 | 000 |
| H679021152510 | K102694 | 000 |
| H67902115250S0 | K102694 | 000 |
| H679021152500 | K102694 | 000 |
| H67902115231S0 | K102694 | 000 |
| H67902115641S0 | K102694 | 000 |