FDA.reportPublic FDA data

VERTICALE

Primary DI
04054896039831
Brand
VERTICALE
Company
Silony Medical GmbH
Model
S-VPS-7235-RS3
Catalog number
S-VPS-7235-RS3
Device description
VERTICALE Reduc Screw ST 7.2x35mm,solid
Published
2018-03-23
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
04054896039831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896039831040548960398314054896039831

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
Length35Millimeter
Outer Diameter7.2Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342538826
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
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28