FDA.reportPublic FDA data

VERTICALE

Primary DI
04054896069647
Brand
VERTICALE
Company
Silony Medical GmbH
Model
S-VOS-4506-2
Catalog number
S-VOS-4506-2
Device description
VERTICALE CERVICAL 2 Occi Screw 4.5x6mm
Published
2021-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054896069647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896069647040548960696474054896069647

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312969760
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840402506430MIDLINE II-TiM331108cM331108c2026-05-19
00840402506478MIDLINE II-TiM331308cM331308c2026-05-19
00840402506553MIDLINE II-TiM331508cM331508c2026-05-19
00840402506638MIDLINE II-TiM331708cM331708c2026-05-19
00840402506713MIDLINE II-TiM331908cM331908c2026-05-19
00840402506874MIDLINE II-TiM361108cM361108c2026-05-19
00840402506911MIDLINE II-TiM361308cM361308c2026-05-19
00840402507017MIDLINE II-TiM361508cM361508c2026-05-19
00840402507116MIDLINE II-TiM361708cM361708c2026-05-19
00840402507123MIDLINE II-TiM361708c-32M361708c-322026-05-19
00840402507154MIDLINE II-TiM361712c-32M361712c-322026-05-19
00840402507215MIDLINE II-TiM361908cM361908c2026-05-19
00840402507376MIDLINE II-TiM391108cM391108c2026-05-19
00840402507413MIDLINE II-TiM391308cM391308c2026-05-19
00840402507499MIDLINE II-TiM391508cM391508c2026-05-19
00840402507604MIDLINE II-TiM391708cM391708c2026-05-19
00840402507611MIDLINE II-TiM391708c-35M391708c-352026-05-19
00840402507642MIDLINE II-TiM391712c-35M391712c-352026-05-19
00840402507710MIDLINE II-TiM391908cM391908c2026-05-19
00840402507871MIDLINE II-TiM421108cM421108c2026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082055ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082062ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082079ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082086ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082093ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05