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510(k) K984375

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY by Osteonics Corp. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1999
Date Received
December 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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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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