510(k) Report

FDA applicant

Zavation, LLC

Flowood, MS15 decisions2011–201736 recalls

FDA records 15 decisions for Zavation, LLC (Flowood, MS) from 2011 to 2017: 15 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 8 of them its own earlier devices. 36 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Zavation, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2017

2011: 32012: 12013: 12014: 32015: 12016: 32017: 3
2011high 3 (2011) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

36in 2021

2021: 36
2011high 36 (2021) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Zavation, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body4decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • PEKSpinous Process Plate1decision
  • NKGPosterior Cervical Screw System1decision

Also: OVD (1), NDN (1), MNH (1), ODP (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 159 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 112 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 45 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130030Zavation Cervical Plate SystemZavation, LLC · 20136cite it
  • K112533Zavation Cervical Plate SystemZavation, LLC · 20115cite it
  • K120576Zavation Ibf SystemZavation, LLC · 20124cite it
  • K112484Zavation Spinal SystemZavation, LLC · 20113cite it
  • K112664Zavation Ibf SystemsZavation, LLC · 20113cite it
  • K160362Z-Span Plate SystemZavation, LLC · 20162cite it

What has FDA decided for it lately?

  • K162206Zavation IBFZavation, LLC · 2017
  • K162575Z-LINKPC SystemZavation, LLC · 2017
  • K162824Z-Span Plate SystemZavation, LLC · 2017
  • K161016Z-Clamp ISP SystemZavation, LLC · 2016
  • K153404Zavation Spinal SystemZavation, LLC · 2016
  • K160362Z-Span Plate SystemZavation, LLC · 2016
  • K142392Zavation Posterior LEIFZavation, LLC · 2015
  • K142271Zavation Z-Link LumbarZavation, LLC · 2014

All 15 as Zavation, LLC →

What has been recalled?

36 recalls linked to its devices; the latest:

  • K14141911G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Mar 25, 2021Class II
  • K141419ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.Mar 25, 2021Class II
  • K14141910G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Mar 25, 2021Class II
  • K14141910G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.Mar 25, 2021Class II
  • K14141910G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.Mar 25, 2021Class II
  • K141419ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For…Mar 25, 2021Class II

Other applicant names beginning “Zavation”

FDA records each applicant name separately; these may or may not be the same firm.

Zavation Medical Products, LLC 31