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510(k) K860225

METRICOM by Far Orthopedics, Inc. — Product Code LDK

K860225 is an FDA 510(k) premarket notification submitted by Far Orthopedics, Inc. for the device "METRICOM". The FDA issued a decision of Substantially Equivalent on February 11, 1986. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device. Far Orthopedics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1986
Date Received
January 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

Other clearances by Far Orthopedics, Inc.

  • K834462 — GENUCOM (February 9, 1984)

Other clearances for product code LDK

  • K230463 — NSite Scoliosis Assessment App (November 15, 2023)
  • K232023 — Momentum Spine (October 4, 2023)
  • K183485 — CryoVizion System (August 28, 2019)
  • K923792 — QUANTEC SPINAL MEASUEMENT SYSTEM (April 20, 1994)
  • K851133 — TERRAN BIOMECHANICAL ANALYSIS SYSTEM (June 19, 1985)
  • K844736 — ISIS (March 21, 1985)
  • K800591 — CONTOUROGRAPH M-500 (April 2, 1980)

FDA data resources