Product code GXR— Neurology

FDA has cleared 29 devices under product code GXR between 1985 and 2026, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20241 clearance
• 20231 clearance
• 20202 clearances
• 20182 clearances
• 20162 clearances
• 20142 clearances
• 20134 clearances
• 20102 clearances
• 20071 clearance
• 20043 clearances
• 20031 clearance
• 20021 clearance
• 20012 clearances
• 20001 clearance

• Synthes (Usa)4 clearances
• Neos Surgery S.L4 clearances
• St Jude Medical2 clearances
• Ossdsign AB2 clearances
• NeuroPace, Inc.2 clearances
• Aesculap, Inc.2 clearances
• W. L. Gore & Associates, Inc.1 clearance
• Tissue Regeneration Systems, Inc.1 clearance
• Prosurg, Inc.1 clearance
• Phoenix Bioengineering, Inc.1 clearance

• K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.·2026-03-16
• K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L·2024-02-16
• K221606 — Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.·2023-11-21
• K192310 — Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.·2020-06-03
• K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC·2020-03-13
• K181539 — OSSDSIGN CranioplugOssdsign AB·2018-10-12
• K181382 — GuardianTM Burr Hole Cover SystemSt Jude Medical·2018-07-20
• K160739 — Cranial COVERNeos Surgery S.L·2016-06-12
• K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical·2016-06-09
• K140309 — CRANIOPLUGOssdsign AB·2014-10-03
• K141368 — NEUROPACE BURR HOLE COVERNeuroPace, Inc.·2014-07-11
• K132044 — CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEMNeos Surgery S.L·2013-09-30
• K123633 — TRS CRANIAL BONE VOID FILLER(TRS C-BVF)Tissue Regeneration Systems, Inc.·2013-08-16
• K130309 — RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEMBiomet Microfixation·2013-06-17
• K123163 — NEUROPACE BURR HOLE COVER MODEL 8110NeuroPace, Inc.·2013-01-18
• K101235 — CRANIAL LOOP CRANIAL BONE FIXATION SYSTEMNeos Surgery S.L·2010-10-25
• K091692 — AESCULAP PEEK CRANIOFIXAesculap, Inc.·2010-08-12
• K071138 — CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEMProsurg, Inc.·2007-08-15
• K042986 — MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEMSynthes (Usa)·2004-11-17
• K041611 — SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMPSynthes (Usa)·2004-09-08
• K040080 — AESCULAP ABSORBABLE CRANIOFIXAesculap, Inc.·2004-03-31
• K031654 — SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)Synthes (Usa)·2003-08-08
• K021408 — RESORBABLE CRANIAL CLAMPSSynthes (Usa)·2002-07-29
• K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900Medtronic PS Medical·2001-05-07
• K002334 — MACROPORENS CRANILOCMacropore Biosurgery, Inc.·2001-05-02
• K001096 — BURR HOLE COVER, MODEL XXImage-Guided Neurologics, Inc.·2000-10-25
• K960656 — GORE BURR HOLE COVERW. L. Gore & Associates, Inc.·1996-08-14
• K913490 — PHOENIX BURR HOLE BUTTON, BURR 1Phoenix Bioengineering, Inc.·1992-01-13
• K853367 — H-H BURR HOLE CATHETER SUPPORTHolter-Hausner Intl.·1985-09-11