510(k) Report

FDA applicant

Avalign Technologies, Inc.

Fort Wayne, IN3 decisions2020–20260 recalls

FDA records 3 decisions for Avalign Technologies, Inc. (Fort Wayne, IN) from 2020 to 2026: 3 510(k) clearances. Most are in product codes OVD (Intervertebral Fusion Device With Integrated…) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 274 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 1 of them its own earlier devices. No 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 Avalign Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 12025: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Avalign Technologies, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avalign Technologies, 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?

  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 274 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 100 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 20251cites it

What has FDA decided for it lately?

  • K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. · 2026
  • K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025
  • K193066Steripack cases and Tray SystemsAvalign Technologies, Inc. · 2020

All 3 as Avalign Technologies, Inc. →