FDA.reportPublic FDA data

Palladian™

Primary DI
00841508107026
Brand
Palladian™
Company
NEUROSTRUCTURES, INC
Model
50-01-6560
Device description
Cannulated, 6.5mm Bone Screw, 60mm
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841508107026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841508107026008415081070268415081070260841508107026

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8003526103customerservice@neurostructures.com

Regulatory Flags#

DUNS number
079391677
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841508104216Cavetto100018-1214102016-01-08
00841508104223Cavetto100018-121442016-01-08
00841508104230Cavetto100018-121452016-01-11
00841508104247Cavetto100018-121462016-01-11
00841508104254Cavetto100018-121472016-01-11
00841508104261Cavetto100018-121482016-01-11
00841508104278Cavetto100018-121492016-01-11
00841508104285Cavetto100018-1416102016-01-11
00841508104292Cavetto100018-141642016-01-11
00841508104308Cavetto100018-141652016-01-11
00841508104315Cavetto100018-141662016-01-11
00841508104322Cavetto100018-141672016-01-11
00841508104339Cavetto100018-141682016-01-11
00841508104346Cavetto100018-141692016-01-11
00841508104353Cavetto100018-161842016-01-11
00841508104360Cavetto100018-161852016-01-11
00841508104377Cavetto100018-161862016-01-11
00841508104384Cavetto100018-161872016-01-11
00841508104391Cavetto100018-161882016-01-11
00841508104407Cavetto100018-161892016-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGKWP2026-05-26
00763000817305VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
00763000817312VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
03662663086233LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091046LineSiderHighridge Medical, LLCKWP2025-10-03
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03662663097369LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097376LineSiderHighridge Medical, LLCKWP2025-10-03
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03662663097413LineSiderHighridge Medical, LLCKWP2025-10-03
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03662663097437LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097444LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097451LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097468LineSiderHighridge Medical, LLCKWP2025-10-03
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03662663097482LineSiderHighridge Medical, LLCKWP2025-10-03
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03662663097505LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097529LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097536LineSiderHighridge Medical, LLCKWP2025-10-03
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03662663097550LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03