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510(k) K140309

CRANIOPLUG by Ossdsign AB — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2014
Date Received
February 7, 2014
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 by Ossdsign AB

  • K232315 — Catalyst Bone Void Filler (September 15, 2023)
  • K212414 — OSSDSIGN Cranial PSI (October 1, 2021)
  • K190523 — Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anato (October 10, 2019)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K161090 — Cranial PSI (January 19, 2017)

Other clearances for product code GXR

  • 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)
  • 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)
  • 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)