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 |