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510(k) K980070

OSTEONICS HA-COATED DEVICES by Osteonics Corp. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1999
Date Received
January 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K983382 — OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM (December 11, 1998)

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