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 |