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510(k) K983226

OSTEONICS X CEMENTED HIP STEM SERIES by Osteonics Corp. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1998
Date Received
September 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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  • K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE (February 24, 1999)
  • K990203 — OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (February 18, 1999)
  • K990158 — OSTEONICS COMBINATION SCREW RING/BLOCKER (February 1, 1999)
  • K984302 — OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS (December 18, 1998)
  • K984353 — OSTEO 9MM IC TIBIAL NAIL (December 16, 1998)
  • K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (December 16, 1998)

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