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510(k) K781443

HARRINGTON SPINE INSTRUMENTATION by Orthopedic Equipment Co., Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1978
Date Received
August 23, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
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)
  • K790209 — FILTER SYSTEM, ALTNER DISPOSABLE (February 26, 1979)
  • K790247 — TOURNIQUET TEST GAGE (February 26, 1979)
  • K781449 — HARRINGTON SPINAL ELEVATOR (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)
  • K781450 — DRIVERS (September 27, 1978)

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