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Viper System, Expedium System

by Depuy Spine, Inc.

510(k) K101993

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 · Special NumberK101993 Date7 Dec 2010ClearedStatusActive

Recalls

8 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0706-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0705-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0708-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0712-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0709-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0707-2013 FDA Class II initiated 7 Nov 2012
    • Terminated Z-0710-2013 FDA Class II initiated 7 Nov 2012

    Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

    • Terminated Z-0713-2013 FDA Class II initiated 7 Nov 2012

    Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

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  • Withdrawn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
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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