FDA.reportPublic FDA data

Xia 3 System - Serrato

Primary DI
07613327352771
Brand
Xia 3 System - Serrato
Company
Stryker Corporation
Model
482615040
Catalog number
482615040
Device description
Polyaxial Screw
Published
2018-02-07
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327352771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327352771076133273527717613327352771

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length40Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
true
Lot or batch
true
Serial number
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
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
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00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203685Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203692Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203708Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203715Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203722Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203739Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203746Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203753Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203760Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203777Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203784Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203791Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203807Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203814Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203821Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203838Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203845Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203852Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203869Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203876Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203883Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203890Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203906Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203913Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203920Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06