The following data is part of a premarket notification filed by Stryker Spine with the FDA for Aero -c Cervical Cage System.
Device ID | K152532 |
510k Number | K152532 |
Device Name: | AERO -C Cervical Cage System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Contact | Soraya King |
Correspondent | Soraya King STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-03 |
Decision Date | 2015-12-18 |
Summary: | summary |