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510(k) K983014

SUMMIT ACETABULAR SYSTEM by Johnson & Johnson Professionals, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1998
Date Received
August 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)
  • K980081 — S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD (April 9, 1998)

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