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510(k) K903938

C FIT CUP by Orthopedic Systems, Inc. — Product Code JDI

Clearance Details

Decision
SN ()
Decision Date
January 4, 1991
Date Received
August 27, 1990
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

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  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K892503 — NUFFIELD TOTAL KNEE (May 4, 1990)
  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)
  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
  • K895219 — CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM (September 12, 1989)

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