510(k) Report

FDA applicant

Camber Spine Technologies

King Of Prussia, PA23 decisions2013–20240 recalls

FDA records 23 decisions for Camber Spine Technologies (King Of Prussia, PA) from 2013 to 2024: 23 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OVD (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 84 predicates, 18 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Camber Spine Technologies, LLC”.

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 Camber Spine Technologies’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2013: 12016: 12017: 52018: 42019: 22020: 12021: 12022: 22023: 32024: 3
2013high 5 (2017) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Camber Spine Technologies by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Camber Spine Technologies’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, Lumbar8decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar3decisions
  • OURSacroiliac Joint Fixation3decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions

Also: OLO (1), NKB (1), MQP (1).

How long do its 510(k) reviews take?

Since 2016, its 22 510(k)s took a median of 135 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 6 of its 22 were faster than that.

Whose devices does it build on?

Its devices cite 84 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 37 times; 18 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.

  • K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 20135cite it
  • K172064Ti-Diagon Oblique TLIFCamber Spine Technologies · 20175cite it
  • K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 20194cite it
  • K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 20174cite it
  • K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC · 20213cite it
  • K162986SPIRA Open Matrix ALIFCamber Spine Technologies · 20173cite it

What has FDA decided for it lately?

  • K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies · 2024
  • K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
  • K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies · 2024
  • K230942SPIRA® Posterior Lumbar SpacersCamber Spine Technologies · 2023
  • K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023
  • K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies · 2023
  • K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC · 2022
  • K220038Camber Spine Navigation SystemCamber Spine Technologies · 2022

All 17 as Camber Spine Technologies →All 6 as Camber Spine Technologies, LLC →

Other applicant names beginning “Camber”

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

Camber Spine 4