FDA.reportPublic FDA data

VERTICALE

Primary DI
04054896038919
Brand
VERTICALE
Company
Silony Medical GmbH
Model
S-VPS-7255-S2
Device description
VERTICALE Poly Screw ST 7.2x55mm,solid
Published
2018-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054896038919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896038919040548960389194054896038919

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
Length55Millimeter
Outer Diameter7.2Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342538826
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054896019710ROCCIAS-RPP-07112305-SS-RPP-07112305-S2019-08-15
04054896019727ROCCIAS-RPP-07112805-SS-RPP-07112805-S2019-08-15
04054896019734ROCCIAS-RPP-08112305-SS-RPP-08112305-S2019-08-15
04054896019741ROCCIAS-RPP-08112310-SS-RPP-08112310-S2019-08-15
04054896019758ROCCIAS-RPP-08112805-SS-RPP-08112805-S2019-08-15
04054896019765ROCCIAS-RPP-08113305-SS-RPP-08113305-S2019-08-15
04054896019772ROCCIAS-RPP-09112305-SS-RPP-09112305-S2019-08-15
04054896019789ROCCIAS-RPP-09112310-SS-RPP-09112310-S2019-08-15
04054896019796ROCCIAS-RPP-09112805-SS-RPP-09112805-S2019-08-15
04054896019802ROCCIAS-RPP-09112810-SS-RPP-09112810-S2019-08-15
04054896019819ROCCIAS-RPP-09113305-SS-RPP-09113305-S2019-08-15
04054896019826ROCCIAS-RPP-10112305-SS-RPP-10112305-S2019-08-15
04054896019833ROCCIAS-RPP-10112310-SS-RPP-10112310-S2019-08-15
04054896019840ROCCIAS-RPP-10112805-SS-RPP-10112805-S2019-08-15
04054896019857ROCCIAS-RPP-10112810-SS-RPP-10112810-S2019-08-15
04054896019864ROCCIAS-RPP-10113305-SS-RPP-10113305-S2019-08-15
04054896019871ROCCIAS-RPP-10113310-SS-RPP-10113310-S2019-08-15
04054896019888ROCCIAS-RPP-11112305-SS-RPP-11112305-S2019-08-15
04054896019895ROCCIAS-RPP-11112310-SS-RPP-11112310-S2019-08-15
04054896019901ROCCIAS-RPP-11112805-SS-RPP-11112805-S2019-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGKWP2026-05-26
00763000817305VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
00763000817312VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
03662663086233LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091046LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091084LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091091LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097345LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097352LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097369LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097376LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097383LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097390LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097406LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097413LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097420LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097437LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097444LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097451LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097468LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097475LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097482LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097499LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097505LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097529LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097536LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097543LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097550LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03