FDA.reportPublic FDA data

Mont Blanc Spinal Systems

Primary DI
03663422002020
Brand
Mont Blanc Spinal Systems
Company
SPINEWAY
Model
1
Catalog number
MB1THO
Device description
TRANSVERSE HOOK
Published
2016-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663422002020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663422002020036634220020203663422002020

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
281075270
Device count
1
Lot or batch
true
Expiration date on label
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
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
03663422040381Blue Mountain Cervical Plate System2BM2P462016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24