The following data is part of a premarket notification filed by Synthes Usa with the FDA for 2.4 Mm Va-lcp Volar Rim Distal Radius System.
| Device ID | K110125 |
| 510k Number | K110125 |
| Device Name: | 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM |
| 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 | 2011-01-18 |
| Decision Date | 2011-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679031158510 | K110125 | 000 |
| H679021157510 | K110125 | 000 |
| H67902115750S00 | K110125 | 000 |
| H679021157500 | K110125 | 000 |
| H67904115851S0 | K110125 | 000 |
| H679041158510 | K110125 | 000 |
| H67904115850S0 | K110125 | 000 |
| H679041158500 | K110125 | 000 |
| H67904115751S0 | K110125 | 000 |
| H679041157510 | K110125 | 000 |
| H67904115750S0 | K110125 | 000 |
| H67902115751S0 | K110125 | 000 |
| H679021158500 | K110125 | 000 |
| H679031158500 | K110125 | 000 |
| H679031158010 | K110125 | 000 |
| H679031158000 | K110125 | 000 |
| H679031157510 | K110125 | 000 |
| H679031157500 | K110125 | 000 |
| H679031157010 | K110125 | 000 |
| H679031157000 | K110125 | 000 |
| H67902115851S0 | K110125 | 000 |
| H679021158510 | K110125 | 000 |
| H67902115850S0 | K110125 | 000 |
| H679041157500 | K110125 | 000 |