FDA.reportPublic FDA data

Oyster

Primary DI
04054896061993
Brand
Oyster
Company
Silony Medical GmbH
Model
S-OCT-08171405-S
Catalog number
S-OCT-08171405-S
Device description
oyster ACIF Cage, 08x17x14mm,wedge shape
Published
2019-09-05
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

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
04054896061993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896061993040548960619934054896061993

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
Height8Millimeter
Length17Millimeter
Width14Millimeter

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
Primary DIBrandCompanyProduct codePublished
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00841193127590EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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