510(k) Report

FDA applicant

Coalign Innovations, Inc.

Washington, DC9 decisions2011–20133 recalls

FDA records 9 decisions for Coalign Innovations, Inc. (Washington, DC) from 2011 to 2013: 9 510(k) clearances. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 21 predicates, 13 of them its own earlier devices. 3 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 Coalign Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2013

2011: 32012: 12013: 5
2011high 5 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

3in 2016

2016: 3
2011high 3 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Coalign Innovations, Inc. 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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar9decisions

Whose devices does it build on?

Its devices cite 21 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 36 times; 13 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.

  • K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc. · 201111cite it
  • K123281Acculif TL-Peek CageCoalign Innovations, Inc. · 20137cite it
  • K123752Acculif TL and PL CageCoalign Innovations, Inc. · 20136cite it
  • K113465Acculif TL CageCoalign Innovations, Inc. · 20115cite it
  • K110270Acculif CageCoalign Innovations, Inc. · 20112cite it
  • K132505Acculif TL and PL CageCoalign Innovations, Inc. · 20132cite it

What has FDA decided for it lately?

  • K132505Acculif TL and PL CageCoalign Innovations, Inc. · 20133 recalls
  • K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc. · 2013
  • K130194Acculif XL CageCoalign Innovations, Inc. · 2013
  • K123281Acculif TL-Peek CageCoalign Innovations, Inc. · 2013
  • K123752Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  • K121683Acculif TL CageCoalign Innovations, Inc. · 2012
  • K113465Acculif TL CageCoalign Innovations, Inc. · 2011
  • K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc. · 2011

All 9 as Coalign Innovations, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K132505AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL…Jul 26, 2016Class II
  • K132505AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages…Jul 26, 2016Class II
  • K132505AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages…Jul 26, 2016Class II