Home GUDID 07350086550108 OSSDSIGN Cranial PSI
Primary DI 07350086550108
Brand OSSDSIGN Cranial PSI
Company Ossdsign AB
Model L
Catalog number 101010
Device description OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)
Published 2017-05-11
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GXN Plate, Cranioplasty, Preformed, Non-Alterable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17350086550105 Package GS1 1 In Commercial Distribution 07350086550108 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17350086550105 17350086550105 07350086550108 07350086550108 7350086550108
GMDN Terms# Term, Definition table Term Definition Cranioplasty plate, non-alterable An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 34 Degrees Celsius
Regulatory Flags# DUNS number 350354370 Device count 1 Premarket exempt true Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810188324665 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-01 00810188324641 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-05-28 00810188324658 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-05-28 00810188324634 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-05-27 08859751210556 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751210563 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751210570 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216206 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216312 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216329 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216336 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216343 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216411 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216428 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216435 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216442 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 00810007631271 AccuShape Medcad GXN 2023-06-23 00810007631288 AccuShape Medcad GXN 2023-06-23 00810007631295 AccuShape Medcad GXN 2023-06-23 00810077248829 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-16 00810077248836 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-16 00810077248973 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-09 00810077248980 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-05 00810077248775 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-03 00810077248997 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-22 00810077249000 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-22 00810077248706 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21 00810077248850 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21 00810077248904 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21 00810077248911 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21