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510(k) K192310

Flap Fixator, Burr Hole Cover by Ossaware Biotech Co., Ltd. — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2020
Date Received
August 26, 2019
Clearance Type
Traditional
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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  • K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl (March 13, 2020)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
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  • 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)
  • K132044 — CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTE (September 30, 2013)