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510(k) K841189

OEC/REZAIAN SPINAL FIXATOR by Orthopedic Equipment Co., Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1984
Date Received
March 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Orthopedic Equipment Co., Inc.

  • K834035 — UNIVERSAL SELF-ALIGNING ACETABULAR COM (June 19, 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)
  • K781449 — HARRINGTON SPINAL ELEVATOR (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)
  • K781443 — HARRINGTON SPINE INSTRUMENTATION (September 27, 1978)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)
  • K781450 — DRIVERS (September 27, 1978)

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