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510(k) K042986

MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM by Synthes (Usa) — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2004
Date Received
October 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

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  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
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Other clearances for product code GXR

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  • K192310 — Flap Fixator, Burr Hole Cover (June 3, 2020)
  • K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl (March 13, 2020)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K160739 — Cranial COVER (June 12, 2016)
  • K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (June 9, 2016)
  • K140309 — CRANIOPLUG (October 3, 2014)
  • K141368 — NEUROPACE BURR HOLE COVER (July 11, 2014)