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Impix Lumbar Interbody Device

by Medicrea Technologies

510(k) K100544

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK100544 Date22 Jul 2010ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2455-2023 FDA Class II initiated 12 Jul 2023

    There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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