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510(k) K780763

ENTRAX TRACTION UNIT by Orthopedic Equipment Co., Inc. — Product Code HSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1978
Date Received
May 8, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Traction, Hip, Non-Powered, Non-Penetrating
Device Class
Class I
Regulation Number
888.5890
Review Panel
OR
Submission Type

Other clearances by Orthopedic Equipment Co., Inc.

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  • 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)