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510(k) K945022

APOFIX CERVICAL SPINE FIXATION by Sofamor Co. — Product Code KWP

Clearance Details

Decision
SN ()
Decision Date
May 15, 1995
Date Received
October 13, 1994
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

Other clearances by Sofamor Co.

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  • K934007 — SOFAMOR ORFIL SPINE FIXATION SYSTEM (June 2, 1994)
  • K873977 — NEW C-D SYSTEM FOR SPINAL SURGERY (December 7, 1987)
  • K843687 — ROD FOR RACHIS SURGERY (January 10, 1985)

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