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510(k) K934007

SOFAMOR ORFIL SPINE FIXATION SYSTEM by Sofamor Co. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1994
Date Received
August 18, 1993
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.

  • K940744 — SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION (January 30, 1996)
  • K945022 — APOFIX CERVICAL SPINE FIXATION (May 15, 1995)
  • K873977 — NEW C-D SYSTEM FOR SPINAL SURGERY (December 7, 1987)
  • K843687 — ROD FOR RACHIS SURGERY (January 10, 1985)

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