FDA.reportPublic FDA data

ROCCIA

Primary DI
04054896034560
Brand
ROCCIA
Company
Silony Medical GmbH
Model
S-RTT-10341205-S
Catalog number
S-RTT-10341205-S
Device description
ROCCIA TLIF Cage 10x34x12mm, 5 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
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054896034560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896034560040548960345604054896034560

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
Angle5degree
Height10Millimeter
Length12Millimeter
Width34Millimeter

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

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Primary DI, Brand, Company table
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