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510(k) K771109

ORTHOPEDIC SOFT GOODS by Orthopedic Systems, Inc. — Product Code HSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1977
Date Received
June 20, 1977
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

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  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K903938 — C FIT CUP (January 4, 1991)
  • K892503 — NUFFIELD TOTAL KNEE (May 4, 1990)
  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)

Other clearances for product code HSS

  • K770910 — MEDISHIELD CERVICAL COLLAR (May 25, 1977)
  • K760869 — SPLIT CERVICAL COLLAR/HEAD HALTER (November 1, 1976)