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510(k) K192310

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

K192310 is an FDA 510(k) premarket notification submitted by Ossaware Biotech Co., Ltd. for the device "Flap Fixator, Burr Hole Cover". The FDA issued a decision of Substantially Equivalent on June 3, 2020. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250.

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

Other clearances for product code GXR

  • K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (March 16, 2026)
  • K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (February 16, 2024)
  • K221606 — Absorbable Cranial Flap Fixation System (November 21, 2023)
  • 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)

FDA data resources