510(k) Report

FDA applicant

Acromed Corp.

Cleveland, OH41 decisions1984–19981 recall

FDA records 41 decisions for Acromed Corp. (Cleveland, OH) from 1984 to 1998: 41 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 15 predicates, 15 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 Acromed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Acromed Corp. since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Acromed 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 Fixation14decisions
  • KWPAppliance, Fixation, Spinal Interlaminal14decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body11decisions
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Who builds on its devices?

Later devices cite its devices 87 times; 15 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.

  • K980485Isola Spinal SystemAcromed Corp. · 199814cite it
  • K971248Kaneda SR Anterior Spinal SystemAcromed Corp. · 19977cite it
  • K974757Kaneda Anterior Scoliosis System KassAcromed Corp. · 19987cite it
  • K962984Isola Pediatric ComponentsAcromed Corp. · 19965cite it
  • K972718M-2 Anterior Plate SystemAcromed Corp. · 19975cite it
  • K952236Isola SystemAcromed Corp. · 19965cite it

What has FDA decided for it lately?

  • K980485Isola Spinal SystemAcromed Corp. · 1998
  • K981714Timx Low Back System Titanium MX Rod Based Low Back SystemAcromed Corp. · 1998
  • K981113Pediatric PRCAcromed Corp. · 1998
  • K981274Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
  • K980228University Plate Anterior SystemAcromed Corp. · 1998
  • K974757Kaneda Anterior Scoliosis System KassAcromed Corp. · 1998
  • K972718M-2 Anterior Plate SystemAcromed Corp. · 1997
  • K970955Acromed Anterior Cervical Stabilization SystemAcromed Corp. · 1997

All 41 as Acromed Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K965098M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and…Oct 11, 2013Class II