FDA.reportPublic FDA data

Ayers Rock Cervical interbody fusion system

Primary DI
03663422600943
Brand
Ayers Rock Cervical interbody fusion system
Company
SPINEWAY
Model
2
Catalog number
063RC8S2
Device description
Rasp 8S, cervical
Published
2017-01-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
03663422600943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663422600943036634226009433663422600943

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33472770152info@spineway.com

Regulatory Flags#

DUNS number
281075270
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663422000118Mont Blanc Spinal Systems1MB1LTH2016-09-08
03663422000699Mont Blanc Spinal Systems1MB1PHO2016-09-08
03663422002020Mont Blanc Spinal Systems1MB1THO2016-09-08
03663422500076MONT BLANC1C1MB032016-08-01
03663422600301MONT BLANC1020HOH12016-08-01
03663422600318MONT BLANC1021HH12016-08-01
03663422600455MONT BLANC2030IHP22016-08-01
03663422600578MONT BLANC1038ET12016-08-01
03663422600585MONT BLANC1039EL12016-08-01
03663422600608MONT BLANC2040EP22016-08-01
03663422601162MONT BLANC1080HCR12016-08-01
03663422040299Blue Mountain Cervical Plate System2BM2P242016-09-12
03663422040305Blue Mountain Cervical Plate System2BM2P272016-09-12
03663422040312Blue Mountain Cervical Plate System2BM2P292016-09-12
03663422040329Blue Mountain Cervical Plate System2BM2P312016-09-12
03663422040336Blue Mountain Cervical Plate System2BM2P342016-09-12
03663422040343Blue Mountain Cervical Plate System2BM2P362016-09-12
03663422040350Blue Mountain Cervical Plate System2BM2P382016-09-12
03663422040367Blue Mountain Cervical Plate System2BM2P412016-09-12
03663422040374Blue Mountain Cervical Plate System2BM2P432016-09-12

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