FDA.reportPublic FDA data

XIA 3

Primary DI
04546540562340
Brand
XIA 3
Company
Stryker Corporation
Model
482317540
Catalog number
482317540
Device description
POLYAXIAL SCREW
Published
2014-12-08
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

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540562340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540562340045465405623404546540562340

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23
07613154757091VertaPlex04064020000406-402-0002016-06-30
07613327141764VertaPlex04064020020406-402-0022016-09-23
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327170566VertaPlex04064020150406-402-0152016-09-23
00808232000214NA2102-01312102-01312015-09-24
07613327124200Vitoss VBA Pack2102-24012102-24012015-12-09
07613327124217Vitoss VBA Pack2101-24052102-24052015-12-09
07613327124224Vitoss VBA Pack2102-24022102-24022015-12-09
07613327124231Vitoss VBA Pack2102-24102102-24102015-12-09
07613327176940NA3102-10023102-10022015-10-24
07613327176957NA3102-12053102-12052015-10-24
07613327176964NA3102-10103102-10102015-10-24
07613327176971NA3102-10013102-10012015-10-24
07613327176988NA3102-12103102-12102015-10-24
07613327176995NA3102-10053102-10052015-10-24
07613327177008NA3102-11103102-11102015-10-24
07613327177015NA3102-11053102-11052015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119355ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119362ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119379ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119386ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119393ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119409ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119416ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119423ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119430ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119447ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119454ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119461ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119478ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119485ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119492ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119508ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119515ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119522ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119539ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119546ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119553ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119560ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119577ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119584ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119591ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119607ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119614ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119621ZAVATION SCREWZavation LLCNKB2026-10-07
00810017916245SABER-XA, Expandable Spacer, 40x30mm, 11mm, (6°)ELEVATION SPINE, INC.KWQ2026-10-07
00810017916252SABER-XA, Expandable Spacer, 40x30mm, 13mm, (12°)ELEVATION SPINE, INC.KWQ2026-10-07