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510(k) K161894

SurgTech Trauma System by Surgtech, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2017
Date Received
July 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K163363 — SurgTech Thoracolumbosacral (TLS) Posterior Fixation System (April 5, 2017)
  • K152200 — SurgTech Interbody System (March 25, 2016)

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