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510(k) K984353

OSTEO 9MM IC TIBIAL NAIL by Osteonics Corp. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1998
Date Received
December 7, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Osteonics Corp.

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  • K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM (March 25, 1999)
  • 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)
  • 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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