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U&I, Optima, Spinal System

by U&I Corp., America 510(k)

Active United States

510(k) K031585

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK031585 Date27 Jun 2003ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

    • Terminated Z-1438-04 FDA Unclassified (pre-2012) initiated 10 Aug 2004 via K031585, on the same 510(k)

    Threads on a set screw, as a component of a spinal fixation system, may break off during use.

  • 2 recalls, same reason

    • Terminated Z-0558-04 FDA Unclassified (pre-2012) initiated 14 Jan 2004 via K031585, on the same 510(k)
    • Terminated Z-0559-04 FDA Unclassified (pre-2012) initiated 14 Jan 2004 via K031585, on the same 510(k)

    Reports of hex driver tips breaking off or becoming worn or stripped.

  • 2 recalls, same reason

    • Terminated Z-1183-03 FDA Unclassified (pre-2012) initiated 18 Aug 2003 via K031585, on the same 510(k)
    • Terminated Z-1182-03 FDA Unclassified (pre-2012) initiated 18 Aug 2003 via K031585, on the same 510(k)

    Reports of pieces chipping off the tip of screwdriver during use.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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