FDA.reportPublic FDA data

RADIUS

Primary DI
04546540546098
Brand
RADIUS
Company
Stryker Corporation
Model
486614024
Catalog number
486614024
Device description
CROSS CONNECTOR
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
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540546098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540546098045465405460984546540546098

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation systemAn assembly of 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. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Millimeter

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
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
04546540722768WingspanM003WS0250090M003WS02500902015-05-29
04546540722775WingspanM003WS0250150M003WS02501502015-05-29
04546540722782WingspanM003WS0250200M003WS02502002015-05-29
04546540722799WingspanM003WS0300090M003WS03000902015-05-29
04546540722805WingspanM003WS0300150M003WS03001502015-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678520297S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520297S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520297S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10