The following data is part of a premarket notification filed by Zavation Llc with the FDA for Zavation Cervical Plate System.
Device ID | K112533 |
510k Number | K112533 |
Device Name: | ZAVATION CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ZAVATION LLC 501 AVALON WAY Brandon, MS 39047 |
Contact | John Walker |
Correspondent | John Walker ZAVATION LLC 501 AVALON WAY Brandon, MS 39047 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-29 |
Decision Date | 2011-12-08 |
Summary: | summary |