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510(k) K885100

MCCONNELL REAMER GUIDE by Mcconnell Orthopedic — Product Code HTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1989
Date Received
December 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Mcconnell Orthopedic

  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K871821 — MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT (May 26, 1987)
  • K871840 — MCCONNELL ORTHOPEDIC ANKLE POSITIONER (May 26, 1987)
  • K871823 — MCCONNELL ORTHOPEDIC TIBIAL POSITIONER (May 26, 1987)
  • K871824 — MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM (May 26, 1987)
  • K871820 — MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT (May 26, 1987)
  • K871822 — MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY (May 26, 1987)
  • K871839 — MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT (May 26, 1987)

Other clearances for product code HTO

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  • K042899 — SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (March 16, 2005)
  • K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (December 21, 2001)
  • K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (June 12, 2000)
  • K954915 — FLEXIBLE INTRAMEDULLARY REAMER (December 28, 1995)
  • K903248 — COMBINATION REAMER (July 30, 1990)
  • K870845 — WARSAW ORTHOPEDIC POINTED REAMER (March 11, 1987)
  • K862933 — ABC-1000 SMALL JOINT REAMERS (August 18, 1986)
  • K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS (October 14, 1983)
  • K811081 — MEDULLARY CANAL SCRAPERS (April 29, 1981)