Valeo Spacer System 11.007.4525

GUDID M555110074525

Valeo PS Screw, ø4.5mm x 25mm, Long

AMEDICA CORPORATION

Bone-screw internal spinal fixation system, sterile
Primary Device IDM555110074525
NIH Device Record Key74f1e016-ac56-40fd-a220-85f9a033f9ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameValeo Spacer System
Version Model NumberC
Catalog Number11.007.4525
Company DUNS028629553
Company NameAMEDICA CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com
Phone801-839-3500
Emailcustomerservice@amedica.com

Device Dimensions

Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM555110074525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

[M555110074525]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-11-14
Device Publish Date2017-12-29

On-Brand Devices [Valeo Spacer System]

M555916006713Valeo II C, 16x14 6° 13-14mm -0.5 Stop
M555916006711Valeo II C, 16x14 6° 11-12mm -0.5 Stop
M555916006709Valeo II C, 16x14 6° 9-10mm -0.5 Stop
M555916006707Valeo II C, 16x14 6° 7-8mm -0.5 Stop
M555916006705Valeo II C, 16x14 6° 5-6mm -0.5 Stop
M555916006613Valeo II C, 14x12 6° 13-14mm -0.5 Stop
M555916006611Valeo II C, 14x12 6° 11-12mm -0.5 Stop
M555916006609Valeo II C, 14x12 6° 9-10mm -0.5 Stop
M555916006607Valeo II C, 14x12 6° 7-8mm -0.5 Stop
M555916006605Valeo II C, 14x12 6° 5-6mm -0.5 Stop
M555916006213Valeo II C, 16x14 0° 13-14mm -0.5 Stop
M555916006211Valeo II C, 16x14 0° 11-12mm -0.5 Stop
M555916006209Valeo II C, 16x14 0° 9-10mm -0.5 Stop
M555916006207Valeo II C, 16x14 0° 7-8mm -0.5 Stop
M555916006205Valeo II C, 16x14 0° 5-6mm -0.5 Stop
M555916006113Valeo II C, 14x12 0° 13-14mm -0.5 Stop
M555916006111Valeo II C, 14x12 0° 11-12mm -0.5 Stop
M555916006109Valeo II C, 14x12 0° 9-10mm -0.5 Stop
M555916006107Valeo II C, 14x12 0° 7-8mm -0.5 Stop
M555916006105Valeo II C, 14x12 0° 5-6mm -0.5 Stop
M555916005014Valeo II Dual Convex Cervical Trial, 14mm
M555916005013Valeo II Dual Convex Cervical Trial, 13mm
M555916005012Valeo II Dual Convex Cervical Trial, 12mm
M555916005011Valeo II Dual Convex Cervical Trial, 11mm
M555916005010Valeo II Dual Convex Cervical Trial, 10mm
M555916005009Valeo II Dual Convex Cervical Trial, 9mm
M555916005008Valeo II Dual Convex Cervical Trial, 8mm
M555916005007Valeo II Dual Convex Cervical Trial, 7mm
M555916005006Valeo II Dual Convex Cervical Trial, 6mm
M555916004614Valeo II 6° 14mm Dual Cervical Trial
M555916004613Valeo II 6° 13mm Dual Cervical Trial
M555916004612Valeo II 6° 12mm Dual Cervical Trial
M555916004611Valeo II 6° 11mm Dual Cervical Trial
M555916004610Valeo II 6° 10mm Dual Cervical Trial
M555916004609Valeo II 6° 9mm Dual Cervical Trial
M555916004608Valeo II 6° 8mm Dual Cervical Trial
M555916004607Valeo II 6° 7mm Dual Cervical Trial
M555916004606Valeo II 6° 6mm Dual Cervical Trial
M555916004605Valeo II 6° 5mm Dual Cervical Trial
M555916004014Valeo II 0° 14mm Dual Cervical Trial
M555916004013Valeo II 0° 13mm Dual Cervical Trial
M555916004012Valeo II 0° 12mm Dual Cervical Trial
M555916004011Valeo II 0° 11mm Dual Cervical Trial
M555916004010Valeo II 0° 10mm Dual Cervical Trial
M555916004009Valeo II 0° 9mm Dual Cervical Trial
M555916004008Valeo II 0° 8mm Dual Cervical Trial
M555916004007Valeo II 0° 7mm Dual Cervical Trial
M555916004006Valeo II 0° 6mm Dual Cervical Trial
M555916004005Valeo II 0° 5mm Dual Cervical Trial
M555916003014Valeo II Convex 14mm Dual Cervical Trial
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