Home / 510(k) Clearances / K181539

510(k) K181539

OSSDSIGN Cranioplug by Ossdsign AB — Product Code GXR

K181539 is an FDA 510(k) premarket notification submitted by Ossdsign AB for the device "OSSDSIGN Cranioplug". The FDA issued a decision of Substantially Equivalent on October 12, 2018. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Ossdsign AB has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2018
Date Received
June 11, 2018
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)
  • K161090 — Cranial PSI (January 19, 2017)
  • K140309 — CRANIOPLUG (October 3, 2014)

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)
  • 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)
  • 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