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HydroSet XT

by Orthovita, Inc.

510(k) K161447

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK161447 Date6 Oct 2016ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0677-2019 FDA Class II initiated 15 Nov 2018

    Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

    • Terminated Z-0678-2019 FDA Class II initiated 15 Nov 2018

    Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19

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  • Withdrawn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
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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