510(k) Report

FDA applicant

Zavation Medical Products, LLC

Flowood, MS31 decisions2018–20260 recalls

FDA records 31 decisions for Zavation Medical Products, LLC (Flowood, MS) from 2018 to 2026: 31 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 87 predicates, 30 of them its own earlier devices. No recall is 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 Medical Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 72019: 52020: 42021: 42022: 42023: 42024: 12025: 12026 (partial year): 1
2018high 7 (2018) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Zavation Medical Products, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zavation Medical Products, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar9decisions
  • NKBThoracolumbosacral Pedicle Screw System7decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body4decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • PLRSpinal Vertebral Body Replacement Device - Cervical2decisions
  • MQVFiller, Bone Void, Calcium Compound2decisions

Also: OLO (1), OVE (1), OUR (1), NKG (1), OVD (1).

How long do its 510(k) reviews take?

Since 2016, its 31 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 92 days; 15 of its 31 were faster than that.

Whose devices does it build on?

Its devices cite 87 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 30 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.

  • K181246Zavation IBF SystemZavation Medical Products, LLC · 20187cite it
  • K200084Zavation IBF SystemZavation Medical Products, LLC · 20203cite it
  • K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 20193cite it
  • K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 20222cite it
  • K211306LabyrinthZavation Medical Products, LLC · 20212cite it
  • K222614Zavation Spinal SystemZavation Medical Products, LLC · 20222cite it

What has FDA decided for it lately?

  • K253943Tiger 2 SystemZavation Medical Products, LLC · 2026
  • K243908Tiger 2 SystemZavation Medical Products, LLC · 2025
  • K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation…Zavation Medical Products, LLC · 2024
  • K231811Zavation Connector SystemZavation Medical Products, LLC · 2023
  • K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC · 2023
  • K230731Zavation ALIF SystemZavation Medical Products, LLC · 2023
  • K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC · 2023
  • K222614Zavation Spinal SystemZavation Medical Products, LLC · 2022

All 31 as Zavation Medical Products, LLC →

Other applicant names beginning “Zavation”

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

Zavation, LLC 15