Product Code: GXN


Products Classified as GXN

3663Plate, Cranioplasty, Preformed, Non-alterablePreformed Nonalterable Cranioplasty Plate.

Total Product Life Cycle (TPLC) Devices

3663Plate, Cranioplasty, Preformed, Non-alterablePreformed Nonalterable Cranioplasty Plate.

Pre-market Notifications for GXN

K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedCAD
K214109PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)Kontour(Xi’an) Medical Technology Co., Ltd.
K212058Longeviti ClearFit™ OTS Cranial ImplantsLongeviti Neuro Solutions, LLC
K210616Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC
K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC
K202901Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC
K193547CustomizedBone ServiceFin-Ceramica Faenza Spa
K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products LLC
K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC
K180513CustomizedBone ServiceFin-Ceramica Faenza S.p.A
K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.
K171507CustomizedBone ServiceFin-ceramica Faenza Spa
K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC
K161090Cranial PSIOSSDSIGN AB
K160707CustomizedBone ServiceFIN-CERAMICA FAENZA SPA

Global Unique Device Identification Database

40613994845021PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00643169103467PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00643169498242PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00643169498006PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00643169497788PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00643169497771PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
40643169496970PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
20643169466306PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00643169466296PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00681490881579PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00681490881555PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00681490881470PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
00810042037670Plate, Cranioplasty, Preformed, Non-Alterable
00810042037618Plate, Cranioplasty, Preformed, Non-Alterable
00810042037601Plate, Cranioplasty, Preformed, Non-Alterable

Maude Adverse Events

ACCUSHAPEMEDCAD2020-03-31
PSI SD800.410 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-19
HTR-PEKKOXFORD PERFORMANCE MATERIALS2020-03-17
UNK - PSI IMPLANTSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
HTR-PEKKOXFORD PERFORMANCE MATERIALS2020-03-05
HTR-PEKKOXFORD PERFORMANCE MATERIALS2020-02-18
HTR-PMI K.S.2002-20191111 TOP RIGHT PARIETAL IMPLANTBIOMET MICROFIXATION2020-02-10
PSI SD800.440 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-10
PSI SD800.440 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-05
HTR-PEKKOXFORD PERFORMANCE MATERIALS2020-02-04
HTR-PEKKOXFORD PERFORMANCE MATERIALS2020-02-03
UNK - PSI IMPLANTSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-23
IPSIPS PEEKKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-01-21
PSI SD800.440 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-15
PSI SD800.434 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-15
PSI SD800.433 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-14
PSI SD800.419 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-14
PSI SD800.434 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-14
PSI SD420.526 TITANIUM IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-13
ACCUSHAPEMEDCAD2020-01-03
ACCUSHAPEMEDCAD2020-01-03
PSI SD800.433 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-19
IPSIPSKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2019-11-08
IPSCRANIALKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2019-11-05
HTR-PEKKOXFORD PERFORMANCE MATERIALS2019-10-25
PSI SD800.541 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-17
PSI SD800.440 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-16
PSI SD800.442 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-11
PSI SD800.534 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-11
PSI 140*120*40 PEEKOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-11
PSI 60*60*40 PEEKOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-11
HTR-PEKKOXFORD PERFORMANCE MATERIALS2019-10-03
PSI SD800.433 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-09-27
PSI SD800.445 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-09-27
HTR-PEKKOXFORD PERFORMANCE MATERIALS2019-09-26
ACCUSHAPEMEDCAD2019-09-25
UNK - PSI IMPLANTSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-09-19
PSI SD800.440 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-09-10
PSI SD800.442 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2019-08-12
CRANIOFIX 2 TITANIUM CLAMP 16MMAESCULAP AG2019-07-26
CRANIOFIX 2 TITANIUM CLAMP 11MMAESCULAP AG2019-07-26
CRANIOFIX 2 TITANIUM CLAMP 16MMAESCULAP AG2019-07-26
CRANIOFIX 2 TITANIUM CLAMP 11MMAESCULAP AG2019-07-26
ACCUSHAPEMEDCAD2019-07-19
PSI SD800.540 PEEK IMPLANTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-07-17
PSI SD800.440 PEEK IMPLANTOBERDORF SYNTHES PRODUKTIONS GMBH2019-07-03
ACCUSHAPEMEDCAD2019-06-26
ACCUSHAPEMEDCAD2019-06-26
HTR-PEKKOXFORD PERFORMANCE MATERIALS2019-06-17
IPSPLATEKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2019-05-23
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.