FDA.reportPublic FDA data

Palladian™

Primary DI
00841508103059
Brand
Palladian™
Company
NEUROSTRUCTURES, INC
Model
50-90-0035
Device description
Small Head Pedicle Sounder
Published
2015-10-16
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
false

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
00841508103059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841508103059008415081030598415081030590841508103059

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

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
03662663091084LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091091LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097345LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097352LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097369LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097376LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097383LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097390LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097406LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097413LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097420LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097437LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097444LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097451LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097468LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097475LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097482LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097499LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097505LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097529LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097536LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097543LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097550LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03