FDA.report

Roccia

Primary DI
04054896009124
Brand
Roccia
Company
Silony Medical GmbH
Model
S-RCP-04141305-S
Catalog number
S-RCP-04141305-S
Device description
ROCCIA ACIF Cage, 4x14x13mm, 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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054896009124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054896009124040548960091244054896009124

GMDN Terms

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

TypeValueUnit
Height4Millimeter
Length13Millimeter
Width14Millimeter

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
04054896019727ROCCIAS-RPP-07112805-SS-RPP-07112805-S2019-08-15
04054896019734ROCCIAS-RPP-08112305-SS-RPP-08112305-S2019-08-15
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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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