Skip to content

Staxx Xd System

by Spine Wave, Inc. 4 variants

510(k) K101288

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 NumberK101288 Date10 Sep 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0967-2011 FDA Unclassified (pre-2012) initiated 22 Oct 2010 on shared 510(k) K101288

    Package Insert Incorrect

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
MQP
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →