Medical Device Manufacturer · US , Brandon , MS

Zavation, LLC

15 submissions · 15 cleared · Since 2011
15
Total
15
Cleared
0
Denied

Zavation, LLC — FDA 510(k) Submissions

Zavation, LLC has submitted 15 FDA 510(k) premarket notifications since 2011, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Appliance, Fixation, Spinal Intervertebral Body, Intervertebral Fusion Device With Bone Graft, Lumbar, Intervertebral Fusion Device With Bone Graft, Cervical, Intervertebral Fusion Device With Integrated Fixation, Cervical, Cement, Bone, Vertebroplasty . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Zavation IBF
K162206 · MAX Intervertebral Fusion... · Orthopedic
Apr 2017 242d
Z-LINKPC System
K162575 · NKG Posterior Cervical Screw... · Orthopedic
Mar 2017 169d
Z-Span Plate System
K162824 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2017 133d
Z-Clamp ISP System
K161016 · PEK Spinous Process Plate · Orthopedic
Oct 2016 191d
Zavation Spinal System
K153404 · MNH Orthosis,... · Orthopedic
Apr 2016 149d
Z-Span Plate System
K160362 · KWQ Appliance, Fixation,... · Orthopedic
Mar 2016 42d
Zavation Posterior LEIF
K142392 · MAX Intervertebral Fusion... · Orthopedic
Apr 2015 245d
Zavation Z-Link Lumbar
K142271 · OVD Intervertebral Fusion... · Orthopedic
Dec 2014 126d
ZVPLASTY
K141419 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Sep 2014 106d
Z-LINK CERVICAL
K141005 · OVE Intervertebral Fusion... · Orthopedic
Aug 2014 111d
ZAVATION CERVICAL PLATE SYSTEM
K130030 · KWQ Appliance, Fixation,... · Orthopedic
Apr 2013 111d
ZAVATION IBF SYSTEM
K120576 · MAX Intervertebral Fusion... · Orthopedic
Mar 2012 30d
ZAVATION IBF SYSTEMS
K112664 · ODP Intervertebral Fusion... · Orthopedic
Dec 2011 101d
ZAVATION CERVICAL PLATE SYSTEM
K112533 · KWQ Appliance, Fixation,... · Orthopedic
Dec 2011 101d
ZAVATION SPINAL SYSTEM
K112484 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Nov 2011 85d
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