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Model 8000 Atlas C-1 Orthogonal Adjusting Instrument

by Spinalight, Inc.

510(k) K946258

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK946258 Date20 Nov 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1809-2013 FDA Class II initiated 6 Mar 2013

    Unapproved medical device

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  • Withdrawn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
LXM
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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