The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Depuy Acromed Vbr System.
Device ID | K030833 |
510k Number | K030833 |
Device Name: | DEPUY ACROMED VBR SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Karen F Jurczak |
Correspondent | Karen F Jurczak DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-17 |
Decision Date | 2003-04-10 |
Summary: | summary |