Mega Plus Super Lag Screw

• • Terminated Z-1865-2008 FDA Unclassified (pre-2012) ·initiated 25 Jan 2005

  Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.

510(k) Number

K930156 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst

  Class II

  FDA 510(k) K911656 Active Cleared 13 Aug 1991

• Duracon Modular Femoral Component and Femoral Spac

  Class II

  FDA 510(k) K920034 Active Cleared 18 Mar 1992

• Schneider Wallstent(R)

  Class II

  FDA 510(k) K911292 Active Cleared 1 May 1991

• Howmedica Alumina Femoral Head

  Class II

  FDA 510(k) K915184 Active Cleared 31 Jan 1992

• Duracon Total Knee System Tibial Components Open recall

  Class II

  FDA 510(k) K915512 Active Cleared 18 Aug 1992

• Bondek Polyglycolic Acid Synthetic Absorb. Suture

  Class II

  FDA 510(k) K905482 Active Cleared 14 Mar 1991

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