FDA.reportPublic FDA data

XIA 3

Primary DI
04546540560421
Brand
XIA 3
Company
Stryker Corporation
Model
48230241
Catalog number
48230241
Device description
SMALL LAMINAR HOOK STANDARD BLADE
Published
2014-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540560421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540560421045465405604214546540560421

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

Regulatory Flags#

DUNS number
149183167
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNI2026-05-25
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00841732117860PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117877PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117884PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117891PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117907PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117914PICASSO IICTL Medical CorporationMNI2023-09-07
00841732118959PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118966PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118973PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118980PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119017PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119024PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119031PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119048PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119055PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119062PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119079PICASSO IICTL Medical CorporationMNI2017-08-08
088000333846944CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2015-12-11