FDA.reportPublic FDA data

Palladian™

Primary DI
00841508106999
Brand
Palladian™
Company
NEUROSTRUCTURES, INC
Model
50-90-0052
Device description
Cross Connector Axial Torque Handle
Published
2016-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841508106999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841508106999008415081069998415081069990841508106999

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841508100003Tempus™10-01-0122016-03-09
00841508100010Tempus™10-01-0142015-09-17
00841508100027Tempus™10-01-0162015-09-17
00841508100034Tempus™10-01-0182015-09-17
00841508100041Tempus™10-01-0202015-09-17
00841508100058Tempus™10-01-0222015-09-17
00841508100065Tempus™10-01-0242015-09-17
00841508100072Tempus™10-01-0262015-09-17
00841508100089Tempus™10-02-0242015-09-17
00841508100096Tempus™10-02-0262015-09-17
00841508100102Tempus™10-02-0282015-09-17
00841508100119Tempus™10-02-0302015-09-17
00841508100126Tempus™10-02-0322015-09-17
00841508100133Tempus™10-02-0342015-09-17
00841508100140Tempus™10-02-0372015-09-17
00841508100157Tempus™10-02-0402015-09-17
00841508100164Tempus™10-02-0432015-09-17
00841508100171Tempus™10-02-0462015-09-17
00841508100188Tempus™10-03-0392015-09-17
00841508100195Tempus™10-03-0422015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153143734XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08