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510(k) K970957

OSTEONICS RESTORATION ACETABULAR RING by Osteonics Corp. — Product Code JDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
March 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

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Other clearances for product code JDJ

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  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962007 — PROTRUSION CAGES (August 1, 1996)
  • K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (June 15, 1993)
  • K890450 — INTERMEDICS APR(TM) II FEMORAL COMPONENT (August 9, 1989)