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510(k) K760869

SPLIT CERVICAL COLLAR/HEAD HALTER by Orthopedic Equipment Co., Inc. — Product Code HSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1976
Date Received
October 18, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Halter, Head, Traction
Device Class
Class I
Regulation Number
888.5890
Review Panel
PM
Submission Type

Other clearances by Orthopedic Equipment Co., Inc.

  • K834035 — UNIVERSAL SELF-ALIGNING ACETABULAR COM (June 19, 1984)
  • K841189 — OEC/REZAIAN SPINAL FIXATOR (May 16, 1984)
  • K800530 — SCHLEIN TRI-SURFACE ANKLE (April 2, 1980)
  • K781445 — SPREADER (September 27, 1979)
  • K790247 — TOURNIQUET TEST GAGE (February 26, 1979)
  • K790209 — FILTER SYSTEM, ALTNER DISPOSABLE (February 26, 1979)
  • K781450 — DRIVERS (September 27, 1978)
  • K781444 — OUTRIGGER DISTRACTION UNIT (September 27, 1978)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)

Other clearances for product code HSS

  • K771109 — ORTHOPEDIC SOFT GOODS (June 27, 1977)
  • K770910 — MEDISHIELD CERVICAL COLLAR (May 25, 1977)