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510(k) K843687

ROD FOR RACHIS SURGERY by Sofamor Co. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1985
Date Received
September 18, 1984
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)

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