FDA.report

VERTICALE

Primary DI
04054896040424
Brand
VERTICALE
Company
Silony Medical GmbH
Model
S-VPS-8280-RF3
Device description
VERTICALE Reduc Screw ST 8.2x80 mm,c+f
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

Related Records

Product Codes

CodeName
NKBThoracolumbosacral pedicle screw system

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054896040424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054896040424040548960404244054896040424

GMDN Terms

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

TypeValueUnit
Length80Millimeter
Outer Diameter8.2Millimeter

Sterilization Methods

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

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04054896019710ROCCIAS-RPP-07112305-SS-RPP-07112305-S2019-08-15
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04054896019789ROCCIAS-RPP-09112310-SS-RPP-09112310-S2019-08-15
04054896019796ROCCIAS-RPP-09112805-SS-RPP-09112805-S2019-08-15
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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
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