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510(k) K240137

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System by Neos Surgery S.L — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2024
Date Received
January 18, 2024
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

Other clearances by Neos Surgery S.L

  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
  • K211613 — Stern Fix Sternal Stabilization System (January 19, 2022)
  • K160739 — Cranial COVER (June 12, 2016)
  • K132044 — CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTE (September 30, 2013)
  • K101235 — CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM (October 25, 2010)

Other clearances for product code GXR

  • 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)
  • 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)