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510(k) K870126

FEMUR WRENCH by Orthopedic Systems, Inc. — Product Code GEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1987
Date Received
January 12, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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Other clearances for product code GEG

  • K891894 — ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE (April 12, 1989)
  • K891899 — ELEVATORS, VARIOUS TYPES (April 12, 1989)
  • K890365 — SEPTUM ELEVATOR (February 3, 1989)
  • K890253 — SURGICAL ELEVATOR (January 27, 1989)
  • K890230 — LIGATURE NEEDLES (January 27, 1989)
  • K872491 — 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS (July 16, 1987)
  • K870781 — ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS (March 9, 1987)
  • K870591 — ELEVATOR, COBB SPINAL (February 26, 1987)
  • K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORS (November 26, 1986)
  • K834176 — H.R. JAKOBI SURG. INSTRUMENTS 40/41 (January 27, 1984)