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510(k) K871703

MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM by Mcconnell Orthopedic — Product Code FWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1987
Date Received
May 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Operating Room Accessories Table Tray
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Mcconnell Orthopedic

  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K885100 — MCCONNELL REAMER GUIDE (January 13, 1989)
  • K871820 — MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM 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)
  • K871821 — MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT (May 26, 1987)
  • K871822 — MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY (May 26, 1987)

Other clearances for product code FWZ

  • K960019 — RETRACTOR ARM CLAMP (February 9, 1996)
  • K945415 — 'LIL MAC ACCESSORY CLAMP(TM) (November 22, 1994)
  • K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)
  • K935381 — KAPS POSITIONING ARM (April 15, 1994)
  • K931037 — WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (July 30, 1993)
  • K926225 — SPONGE COUNTER (March 5, 1993)
  • K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)