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510(k) K050766

EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM by Zimmer Trabecular — Product Code HWE

K050766 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular for the device "EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on May 26, 2005. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Zimmer Trabecular has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2005
Date Received
March 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Zimmer Trabecular

  • K061155 — VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM (September 22, 2006)
  • K061067 — TRABECULAR METAL ACETABULAR AUGMENTS (May 25, 2006)
  • K053340 — TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS (February 27, 2006)
  • K052950 — THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM (November 16, 2005)
  • K051756 — MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ (July 27, 2005)
  • K050937 — TRABECULAR METAL ACETABULAR REVISION SHELLS (May 11, 2005)
  • K050101 — THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 (April 15, 2005)
  • K042871 — TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212- (December 21, 2004)
  • K043061 — THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, M (November 23, 2004)

Other clearances for product code HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)
  • K973560 — BONE GRAFT HARVESTER (November 12, 1997)

FDA data resources