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510(k) K162884

SpineGuard DSG Zavation Screw System by Spineguard S.A. — Product Code HBG

K162884 is an FDA 510(k) premarket notification submitted by Spineguard S.A. for the device "SpineGuard DSG Zavation Screw System". The FDA issued a decision of Substantially Equivalent on January 12, 2017. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Spineguard S.A. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2017
Date Received
October 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

Other clearances by Spineguard S.A.

  • K241895 — Cannulated PsiFGuard (September 26, 2024)
  • K220160 — PediGuard Threaded (March 31, 2022)
  • K201454 — DSG Connect Technology (February 10, 2021)
  • K152747 — DSG Threaded Drill System (June 10, 2016)
  • K143159 — Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGua (January 23, 2015)
  • K123390 — PEDIGUARD NERVE DETECTOR SYSTEM (August 8, 2013)

Other clearances for product code HBG

  • K252696 — LEGACY (November 21, 2025)
  • K153587 — Taps for Resorbable Screws (January 18, 2017)
  • K160129 — MRII Cranial Drill and Accessories (March 26, 2016)
  • K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (July 8, 2015)
  • K122456 — MRII CRAINIAL DRILL (March 22, 2013)
  • K022712 — HAND DRILL, MODEL 11-9901-7 (November 12, 2002)
  • K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES (October 18, 2002)
  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)
  • K915546 — PS MEDICAL VENTRICULOSTOMY KIT (December 30, 1991)

FDA data resources