The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Locking Hand Plates.
| Device ID | K092247 |
| 510k Number | K092247 |
| Device Name: | SYNTHES LOCKING HAND 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 | 2009-07-28 |
| Decision Date | 2009-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679446355S0 | K092247 | 000 |
| H679447354S0 | K092247 | 000 |
| H679447355S0 | K092247 | 000 |
| H679242531S0 | K092247 | 000 |
| H679247354S0 | K092247 | 000 |
| H679247355S0 | K092247 | 000 |
| H679246354S0 | K092247 | 000 |
| H679246355S0 | K092247 | 000 |
| H679446354S0 | K092247 | 000 |
| H679442531S0 | K092247 | 000 |