510(k) Report

FDA applicant

Altiva Corp.

Charlotte, NC5 decisions2005–20071 recall

FDA records 5 decisions for Altiva Corp. (Charlotte, NC) from 2005 to 2007: 5 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 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 Altiva Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Altiva Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Altiva Corp.’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?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation3decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 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.

  • K061482Altes Buttress Plating SystemAltiva Corp. · 20063cite it
  • K051216Hydralok SystemAltiva Corp. · 20053cite it
  • K070891Altiva Classic Acp SystemAltiva Corp. · 20072cite it

What has FDA decided for it lately?

  • K070891Altiva Classic Acp SystemAltiva Corp. · 2007
  • K061482Altes Buttress Plating SystemAltiva Corp. · 2006
  • K053070Contour II Spinal SystemAltiva Corp. · 2006
  • K051044Arctec Semirigid Plating SystemAltiva Corp. · 2005
  • K051216Hydralok SystemAltiva Corp. · 20051 recall

All 5 as Altiva Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051216Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107.…Mar 6, 2009Class II