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 |