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510(k) K892503

NUFFIELD TOTAL KNEE by Orthopedic Systems, Inc. — Product Code JWH

Clearance Details

Decision
SN ()
Decision Date
May 4, 1990
Date Received
April 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
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  • 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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