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510(k) K160739

Cranial COVER by Neos Surgery S.L — Product Code GXR

K160739 is an FDA 510(k) premarket notification submitted by Neos Surgery S.L for the device "Cranial COVER". The FDA issued a decision of Substantially Equivalent on June 12, 2016. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Neos Surgery S.L has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2016
Date Received
March 17, 2016
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 Neos Surgery S.L

  • K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (February 16, 2024)
  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
  • K211613 — Stern Fix Sternal Stabilization System (January 19, 2022)
  • 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

  • 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)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • 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