The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Bengal Stackable Cage System.
Device ID | K073649 |
510k Number | K073649 |
Device Name: | BENGAL STACKABLE CAGE SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Sharon Slarowicz |
Correspondent | Sharon Slarowicz DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-26 |
Decision Date | 2008-01-25 |
Summary: | summary |