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510(k) K871823

MCCONNELL ORTHOPEDIC TIBIAL POSITIONER by Mcconnell Orthopedic — Product Code FWZ

K871823 is an FDA 510(k) premarket notification submitted by Mcconnell Orthopedic for the device "MCCONNELL ORTHOPEDIC TIBIAL POSITIONER". The FDA issued a decision of Substantially Equivalent on May 26, 1987. The device falls under product code FWZ (Operating Room Accessories Table Tray), a Class I device regulated under 21 CFR 878.4950. Mcconnell Orthopedic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1987
Date Received
May 11, 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)
  • K871821 — MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT (May 26, 1987)
  • K871840 — MCCONNELL ORTHOPEDIC ANKLE POSITIONER (May 26, 1987)
  • K871820 — MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT (May 26, 1987)
  • K871822 — MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY (May 26, 1987)
  • K871824 — MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM (May 26, 1987)
  • K871839 — MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT (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)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)

FDA data resources