The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Depuy Synthes Spine Dens Access System.
Device ID | K132910 |
510k Number | K132910 |
Device Name: | DEPUY SYNTHES SPINE DENS ACCESS SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | SYNTHES USA PRODUCTS, LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Contact | Eugene Bang |
Correspondent | Eugene Bang SYNTHES USA PRODUCTS, LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-17 |
Decision Date | 2013-12-16 |
Summary: | summary |