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510(k) K980081

S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD by Johnson & Johnson Professionals, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1998
Date Received
January 9, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

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