FDA.reportPublic FDA data

NeuroPro®

Primary DI
00898142001210
Brand
NeuroPro®
Company
Kinamed, Inc.
Model
14-1S1-1606
Catalog number
14-1S1-1606
Device description
Bone Screw, 1.6 x 6mm
Published
2015-11-09
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
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898142001210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898142001210008981420012108981420012100898142001210

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate screwA small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or congenital anomaly or disease.

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
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
00818720010106SuperCable® Grip and Plate System35-220-301235-220-30122015-10-28
00898142001906NeuroPro®14-1P1-127714-1P1-12772023-05-15
00898142001005NeuroPro®14-1P1-021114-1P1-02112015-11-09
00898142001029NeuroPro®14-1P1-081014-1P1-08102015-11-05
00898142001036NeuroPro®14-1P1-081214-1P1-08122015-11-05
00898142001050NeuroPro®14-1P1-041314-1P1-04132015-11-05
00898142001067NeuroPro®14-1P2-011414-1P2-01142015-11-05
00898142001074NeuroPro®14-1P2-011814-1P2-01182015-11-05
00898142001081NeuroPro®14-1P2-021814-1P2-02182015-11-05
00898142001098NeuroPro®14-1P2-031814-1P2-03182015-11-05
00898142001104NeuroPro®14-1P2-012214-1P2-01222015-11-05

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03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
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