Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K210497Substantially equivalent (SESE) · 2021-07-07clearance family

Predicate lineage

Cited as predicate by: K222028, K230708, K240566, K240830, K241466

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-02-24WLWarning LetterIsoTis OrthoBiologics, Inc.—
2025-10-17OAIOfficial action indicatedIsoTis OrthoBiologics, Inc.3
2022-04-22NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
2022-04-22NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
2018-08-14NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
2018-08-14NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
2015-09-25NAINo action indicatedIsoTis OrthoBiologics, Inc.0
2012-04-27NAINo action indicatedIsoTis OrthoBiologics, Inc.0
Similar devices
Select up to two to place side-by-side with this device.