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510(k) K984585

OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE by Osteonics Corp. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1999
Date Received
December 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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  • K990158 — OSTEONICS COMBINATION SCREW RING/BLOCKER (February 1, 1999)
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  • K984353 — OSTEO 9MM IC TIBIAL NAIL (December 16, 1998)
  • K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (December 16, 1998)
  • K983382 — OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM (December 11, 1998)

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