The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Distraction Osteogenesis System, Mr Conditional With Expanded Indications.
| Device ID | K092190 |
| 510k Number | K092190 |
| Device Name: | SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Jill R Yelton |
| Correspondent | Jill R Yelton SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2010-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679033112150 | K092190 | 000 |
| H679033110460 | K092190 | 000 |
| H679033110380 | K092190 | 000 |
| H679033110370 | K092190 | 000 |
| H679033110250 | K092190 | 000 |
| H679033110240 | K092190 | 000 |
| H679033110230 | K092190 | 000 |
| H679033110220 | K092190 | 000 |
| H679033110200 | K092190 | 000 |
| H679033110470 | K092190 | 000 |
| H679033110480 | K092190 | 000 |
| H679033110540 | K092190 | 000 |
| H679033112140 | K092190 | 000 |
| H679033112130 | K092190 | 000 |
| H679033112120 | K092190 | 000 |
| H679033111750 | K092190 | 000 |
| H679033111740 | K092190 | 000 |
| H679033111730 | K092190 | 000 |
| H679033111720 | K092190 | 000 |
| H679033111710 | K092190 | 000 |
| H679033110150 | K092190 | 000 |