Blue Mountain Cervical Plate System BM2P48

GUDID 03663422040398

CERVICAL PLATE L:48mm

SPINEWAY

Spinal fixation plate, non-bioabsorbable
Primary Device ID03663422040398
NIH Device Record Keye3701a33-dc2b-4e7e-a1b6-39a853deb3f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlue Mountain Cervical Plate System
Version Model Number2
Catalog NumberBM2P48
Company DUNS281075270
Company NameSPINEWAY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com
Phone+33472770152
Emailinfo@spineway.com

Device Dimensions

Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter
Length48 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103663422040398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

[03663422040398]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2016-09-12

On-Brand Devices [Blue Mountain Cervical Plate System]

03663422040282CERVICAL CENTRAL SCREW Ø:4,5 L:18mm
03663422040275CERVICAL CENTRAL SCREW Ø:4,5 L:16mm
03663422040268CERVICAL CENTRAL SCREW Ø:4,5 L:14mm
03663422040251CERVICAL CENTRAL SCREW Ø:4,5 L:12mm
03663422040244CERVICAL CENTRAL SCREW Ø:4 L:18mm
03663422040237CERVICAL CENTRAL SCREW Ø:4 L:16mm
03663422040220CERVICAL CENTRAL SCREW Ø:4 L:14mm
03663422040213CERVICAL CENTRAL SCREW Ø:4 L:12mm
03663422040206CERVICAL DISTAL SCREW Ø:4,5 L:20mm
03663422040190CERVICAL DISTAL SCREW Ø:4,5 L:18mm
03663422040183CERVICAL DISTAL SCREW Ø:4,5 L:16mm
03663422040176CERVICAL DISTAL SCREW Ø:4,5 L:14mm
03663422040169CERVICAL DISTAL SCREW Ø:4,5 L:12mm
03663422040152CERVICAL DISTAL SCREW Ø:4,0 L:20mm
03663422040145CERVICAL DISTAL SCREW Ø:4,0 L:18mm
03663422040138CERVICAL DISTAL SCREW Ø:4,0 L:16mm
03663422040121CERVICAL DISTAL SCREW Ø:4,0 L:14mm
03663422040114CERVICAL DISTAL SCREW Ø:4,0 L:12mm
03663422040008SCREW FOR CAGE FIXATION
03663422040558CERVICAL PLATE L:93mm
03663422040541CERVICAL PLATE L:90mm
03663422040534CERVICAL PLATE L:87mm
03663422040527CERVICAL PLATE L:84mm
03663422040510CERVICAL PLATE L:81mm
03663422040503CERVICAL PLATE L:78mm
03663422040497CERVICAL PLATE L:75mm
03663422040480CERVICAL PLATE L:72mm
03663422040473CERVICAL PLATE L:69mm
03663422040466CERVICAL PLATE L:66mm
03663422040459CERVICAL PLATE L:62mm
03663422040442CERVICAL PLATE L:58mm
03663422040435CERVICAL PLATE L:56mm
03663422040428CERVICAL PLATE L:54mm
03663422040411CERVICAL PLATE L:52mm
03663422040404CERVICAL PLATE L:50mm
03663422040398CERVICAL PLATE L:48mm
03663422040381CERVICAL PLATE L:46mm
03663422040374CERVICAL PLATE L:43mm
03663422040367CERVICAL PLATE L:41mm
03663422040350CERVICAL PLATE L:38mm
03663422040343CERVICAL PLATE L:36mm
03663422040336CERVICAL PLATE L:34mm
03663422040329CERVICAL PLATE L:31mm
03663422040312CERVICAL PLATE L:29mm
03663422040305CERVICAL PLATE L:27mm
03663422040299CERVICAL PLATE L:24mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.