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510(k) K923807

P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS by Johnson & Johnson International — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1992
Date Received
July 29, 1992
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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  • K922918 — BARRIER SAF-TE HYDROGEL DRAPE (July 6, 1993)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K901456 — ORTHOSORB(R) ABSORBABLE PIN (August 15, 1990)
  • K900638 — P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (April 30, 1990)
  • K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (September 28, 1989)

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