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Avanta Orthopaedics Trapezial Implant

by Avanta Orthopaedics, Inc.

510(k) K964381

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK964381 Date22 Jan 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0710-03 FDA Unclassified (pre-2012) initiated 24 Jan 2003

    Wrong silicone elastomer used in construction.

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  • Withdrawn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
KYI
Device Class
Class II
Regulation
21 CFR Part 888.3770
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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