510(k) Report

FDA applicant

Amendia, Inc.

Marietta, GA16 decisions2009–20167 recalls

FDA records 16 decisions for Amendia, Inc. (Marietta, GA) from 2009 to 2016: 16 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 177 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 47 predicates, 7 of them its own earlier devices. 7 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 Amendia, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

7in 2016

2009: 12010: 12011: 12014: 22015: 42016: 7
2009high 7 (2016) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2018

2016: 32017: 22018: 2
2009high 3 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Amendia, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System4decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
  • MRWSystem, Facet Screw Spinal Device2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

Also: MQP (1), OVD (1).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 177 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 47 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 7 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.

  • K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 20167cite it
  • K151322Amendia Interbody Fusion DevicesAmendia, Inc. · 20156cite it
  • K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-LinkAmendia, Inc. · 20144cite it
  • K100265Diamond Anterior Cervical Plate SystemAmendia, Inc. · 20104cite it
  • K092568Spartan S3 Facet SystemAmendia, Inc. · 20094cite it
  • K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 20143cite it

What has FDA decided for it lately?

  • K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  • K161842Overwatch Spine SystemAmendia, Inc. · 20161 recall
  • K152920Savannah-T® Pedicle Screw SystemAmendia, Inc. · 20161 recall
  • K153152Syzygy Stabilization SystemAmendia, Inc. · 20162 recalls
  • K160291Optimus ALIF SystemAmendia, Inc. · 2016
  • K152972Amendia Stand-Alone Cervical SystemAmendia, Inc. · 20162 recalls
  • K151310Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  • K152460Rectangular Corpectomy CageAmendia, Inc. · 2015

All 16 as Amendia, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K133036Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each…Jul 16, 2018Class II
  • K150395AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF…Apr 16, 2018Class II
  • K153152Mac Pin Non-Cannulated Screw, 6.5 x 60mmJul 7, 2017Class II
  • K152972Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling…Jul 7, 2017Class II
  • K151322Zeus-P Lumbar Interbody DeviceNov 22, 2016Class II
  • K161842Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm…Nov 22, 2016Class II