FDA.reportPublic FDA data

ROCCIA

Primary DI
04054896034171
Brand
ROCCIA
Company
Silony Medical GmbH
Model
S-RTT-07281100-S
Catalog number
S-RTT-07281100-S
Device description
ROCCIA TLIF Cage 07x28x11mm, 0 Lor.
Published
2018-12-17
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
MAXIntervertebral fusion device with bone graft, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054896034171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896034171040548960341714054896034171

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Height7Millimeter
Length11Millimeter
Width28Millimeter

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

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