FDA.reportPublic FDA data

Roccia

Primary DI
04054896009322
Brand
Roccia
Company
Silony Medical GmbH
Model
S-RCP-06141305-S
Catalog number
S-RCP-06141305-S
Device description
ROCCIA ACIF Cage, 6x14x13mm, wedge shape
Published
2017-05-22
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
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054896009322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896009322040548960093224054896009322

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Millimeter
Length13Millimeter
Width14Millimeter

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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Primary DI, Brand, Company table
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07640185341807SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341746SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-07
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