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Nfix Ii Pedicle Screw System

by N Spine, Inc. 510(k)

Active United States

510(k) K061774

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK061774 Date13 Dec 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

7 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2346-2010 FDA Unclassified (pre-2012) initiated 9 Feb 2009
    • Terminated Z-2344-2010 FDA Unclassified (pre-2012) initiated 9 Feb 2009
    • Terminated Z-2347-2010 FDA Unclassified (pre-2012) initiated 9 Feb 2009
    • Terminated Z-2348-2010 FDA Unclassified (pre-2012) initiated 9 Feb 2009
    • Terminated Z-2345-2010 FDA Unclassified (pre-2012) initiated 9 Feb 2009

    package integrity compromised

  • 2 recalls, same reason

    • Terminated Z-0964-2009 FDA Unclassified (pre-2012) initiated 7 Nov 2008
    • Terminated Z-0963-2009 FDA Unclassified (pre-2012) initiated 7 Nov 2008

    the dimensional specifications are incorrect

Specification

510(k)

510(k) Number
FDA Product Code
NQP
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESU

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