FDA 510(k) Applications Submitted by Synthes USA Products, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K132910 |
09/17/2013 |
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM |
SYNTHES USA PRODUCTS, LLC |
| K103822 |
12/30/2010 |
SYNTHES HEMOSTATIC BONE PUTTY (HBP) |
SYNTHES USA PRODUCTS, LLC |
| K142838 |
09/30/2014 |
Synapse Occipital-Cervical-Thoracic (OCT) System |
SYNTHES USA PRODUCTS, LLC |
| K141897 |
07/14/2014 |
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM |
SYNTHES USA PRODUCTS, LLC |
| K180541 |
03/01/2018 |
DePuy Synthes 2.0 mm Quick Insertion Screws |
Synthes USA Products, LLC |
| K170818 |
03/20/2017 |
Craniomaxillofacial Distraction System (CMFD) |
Synthes USA Products, LLC |
| K162594 |
09/16/2016 |
Craniomaxillofacial Distraction System (CMFD) |
SYNTHES USA PRODUCTS, LLC |
| K161616 |
06/13/2016 |
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannu |
Synthes USA Products, LLC |
| K143285 |
11/17/2014 |
Mandible External Fixator - MR Conditional |
Synthes USA Products, LLC |
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