FDA.reportPublic FDA data

Blue Mountain Cervical Plate System

Primary DI
03663422040558
Brand
Blue Mountain Cervical Plate System
Company
SPINEWAY
Model
2
Catalog number
BM2P93
Device description
CERVICAL PLATE L:93mm
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150036000Blue Mountain Cervical Plate SystemSpineway2015-05-07KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663422040558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663422040558036634220405583663422040558

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length93Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606168533SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168557SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168571SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168588SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168595SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168601SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168618SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168625SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168632SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168656SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168663SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168687SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168694SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168717SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168748SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168755SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168779SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168786SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168809SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168816SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168830SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168847SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168861SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168878SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168892SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168908SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168922SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168939SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169769SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169776SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27