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510(k) K160584

Surgical Navigation Advanced Platform (SNAP) by Surgical Theater, LLC — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2016
Date Received
March 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K170793 — SuRgical Planner (SRP) (February 12, 2018)
  • K140819 — SURGICAL NAVIGATION ADVANCED PLATFORM (June 27, 2014)
  • K123023 — SURGERY REHEARSAL PLATFORM (February 8, 2013)

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