FDA.reportPublic FDA data

NeuroPro® Low Profile

Primary DI
00898142001944
Brand
NeuroPro® Low Profile
Company
Kinamed, Inc.
Model
16-1P3-3867
Catalog number
16-1P3-3867
Device description
Plate Panel, 0.4mm
Published
2015-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GWOPlate, cranioplasty, preformed, alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898142001944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898142001944008981420019448981420019440898142001944

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty sheetA flat piece of implantable metal (typically tantalum) designed to repair small cranial bone defects (i.e., cranioplasty). It is usually perforated and can be shaped to a desired contour using a mallet and a wood block and cut with shears to an appropriate dimension, intraoperatively. Prefabricated metallic plates, which may be manufactured from metallic sheets, are frequently used to repair larger cranial bone defects.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184896645
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818720013398SuperCable® ISO-Elastic™ Cerclage System35-800-303235-800-30322026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage System35-800-305235-800-30522026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage System35-800-312235-800-31222026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage System35-800-325235-800-32522026-07-22
00818720013435KineMatch® PFR System22-820-100122-800-10012026-07-22
00818720013442KineMatch® PFR System22-820-100222-800-10022026-07-22
00818720013305SuperCable® ISO-Elastic™ Cerclage System35-880-206035-880-20602022-10-03
00818720013312SuperCable® ISO-Elastic™ Cerclage System35-880-106035-880-10602022-10-03
00818720013329SuperCable® ISO-Elastic™ Cerclage System35-880-104035-880-10402022-10-03
00818720013336SuperCable® ISO-Elastic™ Cerclage System35-880-204035-880-20402022-10-03
00818720013299SuperCable® ISO-Elastic™ Cerclage System35-880-306035-880-30602022-09-27
00818720013381SuperCable® ISO-Elastic™ Cerclage System35-800-302235-800-30222026-05-29
00818720010007SuperCable® Grip and Plate System35-200-101035-200-10102015-10-28
00818720010014SuperCable® Grip and Plate System35-200-102035-200-10202015-10-28
00818720010021SuperCable® Grip and Plate System35-200-103035-200-10302015-10-28
00818720010038SuperCable® Grip and Plate System35-200-104035-200-10402015-10-27
00818720010069SuperCable® Grip and Plate System35-220-101035-220-10102015-10-28
00818720010076SuperCable® Grip and Plate System35-220-201035-220-20102015-10-28
00818720010083SuperCable® Grip and Plate System35-220-201235-220-20122015-10-28
00818720010090SuperCable® Grip and Plate System35-220-301035-220-30102015-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810125929892CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929908FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929915CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929922CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929939CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929946CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929953CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929960CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929977CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929984CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929861CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929878CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929885CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
00810125929823CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929830FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929847CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929854CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929687CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929694CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929700CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929717FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929724CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929731CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929748FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929755CUSTOMIZED CRANIOFACIAL IMPLANT (CCI)KELYNIAM GLOBAL, INC.GWO2026-06-10
00810125929663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929670FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929625CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929649CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01