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510(k) K834035

UNIVERSAL SELF-ALIGNING ACETABULAR COM by Orthopedic Equipment Co., Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
November 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Orthopedic Equipment Co., Inc.

  • 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)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)
  • K781444 — OUTRIGGER DISTRACTION UNIT (September 27, 1978)
  • K781443 — HARRINGTON SPINE INSTRUMENTATION (September 27, 1978)
  • K781450 — DRIVERS (September 27, 1978)

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