The following data is part of a premarket notification filed by Stryker Spine with the FDA for Avs Anchor-c Cervical Cage System.
Device ID | K102606 |
510k Number | K102606 |
Device Name: | AVS ANCHOR-C CERVICAL CAGE SYSTEM |
Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Contact | Kimberly Lane |
Correspondent | Kimberly Lane STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Product Code | OVE |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-10 |
Decision Date | 2011-04-22 |
Summary: | summary |