The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 2.4mm Va-lcp Intercarpal Fusion System.
Device ID | K103243 |
510k Number | K103243 |
Device Name: | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
Contact | Christopher Hack |
Correspondent | Christopher Hack 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 | 2010-11-01 |
Decision Date | 2011-01-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H67902111304100 | K103243 | 000 |
H67904111300S0 | K103243 | 000 |
H679041113010 | K103243 | 000 |
H67904111301S0 | K103243 | 000 |
H679021113000 | K103243 | 000 |
H67902111300S0 | K103243 | 000 |
H679021113010 | K103243 | 000 |
H67902111301S0 | K103243 | 000 |
H67902111304010 | K103243 | 000 |
H679031110340 | K103243 | 000 |
H679031110350 | K103243 | 000 |
H679031110360 | K103243 | 000 |
H679031110370 | K103243 | 000 |
H679031110420 | K103243 | 000 |
H679031110430 | K103243 | 000 |
H679031110320 | K103243 | 000 |
H679031110330 | K103243 | 000 |
H679031110400 | K103243 | 000 |
H679041113000 | K103243 | 000 |