The following data is part of a premarket notification filed by Depuy Motech Acromed with the FDA for Stackable Cage System.
Device ID | K990148 |
510k Number | K990148 |
Device Name: | STACKABLE CAGE SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | DEPUY MOTECH ACROMED 325 PARAMOUNT DR. Rayham, MA 02767 -0350 |
Contact | William Christianson |
Correspondent | William Christianson DEPUY MOTECH ACROMED 325 PARAMOUNT DR. Rayham, MA 02767 -0350 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-19 |
Decision Date | 1999-09-03 |
Summary: | summary |