The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Hybrid External Fixator Modifications.
Device ID | K073135 |
510k Number | K073135 |
Device Name: | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Contact | Jill Sherman |
Correspondent | Jill Sherman SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Product Code | LXT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-07 |
Decision Date | 2008-01-29 |
Summary: | summary |