Valeo Fusion System 11.004.1015

GUDID M555110041015

Valeo PL,9x21, 0°, 15mm

AMEDICA CORPORATION

Vertebral body prosthesis
Primary Device IDM555110041015
NIH Device Record Key3c015e83-29a0-4549-8cbe-d218a9974a1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameValeo Fusion System
Version Model NumberC
Catalog Number11.004.1015
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
Phone801-839-3500
Emailcustomerservice@amedica.com

Device Dimensions

Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree
Height15 Millimeter
Width21 Millimeter
Length9 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM555110041015 [Primary]

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

[M555110041015]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-24
Device Publish Date2018-01-01

On-Brand Devices [Valeo Fusion System]

M555910099021Amedica VBR Small Trial Caddy Assembly
M555910099011Amedica Trial Case, Case Assembly
M555910099002Valeo VBR Trial Caddy
M555910095510Valeo Corpectomy Caliper
M555110041610Valeo PL,9x21, 6°, 10mm
M555110041609Valeo PL,9x21, 6°, 9mm
M555110041608Valeo PL,9x21, 6°, 8mm
M555110041607Valeo PL,9x21, 6°, 7mm
M555110041015Valeo PL,9x21, 0°, 15mm
M555110091630Valeo Corpectomy 16x12mm, 6°, 30mm Height
M555110091629Valeo Corpectomy 16x12mm, 6°, 29mm Height
M555110091628Valeo Corpectomy 16x12mm, 6°, 28mm Height
M555110091627Valeo Corpectomy 16x12mm, 6°, 27mm Height
M555110091626Valeo Corpectomy 16x12mm, 6°, 26mm Height
M555110091625Valeo Corpectomy 16x12mm, 6°, 25mm Height
M555110091624Valeo Corpectomy 16x12mm, 6°, 24mm Height
M555110091623Valeo Corpectomy 16x12mm, 6°, 23mm Height
M555110091622Valeo Corpectomy 16x12mm, 6°, 22mm Height
M555110091621Valeo Corpectomy 16x12mm, 6°, 21mm Height
M555110091620Valeo Corpectomy 16x12mm, 6°, 20mm Height
M555110091619Valeo Corpectomy 16x12mm, 6°, 19mm Height
M555110091618Valeo Corpectomy 16x12mm, 6°, 18mm Height
M555110091617Valeo Corpectomy 16x12mm, 6°, 17mm Height
M555110091616Valeo Corpectomy 16x12mm, 6°, 16mm Height
M555110091615Valeo Corpectomy 16x12mm, 6°, 15mm Height
M555110091614Valeo Corpectomy 16x12mm, 6°, 14mm Height
M555110091613Valeo Corpectomy 16x12mm, 6°, 13mm Height
M555110091030Valeo Corpectomy 16x12mm, 0°, 30mm Height
M555110091029Valeo Corpectomy 16x12mm, 0°, 29mm Height
M555110091028Valeo Corpectomy 16x12mm, 0°, 28mm Height
M555110091027Valeo Corpectomy 16x12mm, 0°, 27mm Height
M555110091026Valeo Corpectomy 16x12mm, 0°, 26mm Height
M555110091025Valeo Corpectomy 16x12mm, 0°, 25mm Height
M555110091024Valeo Corpectomy 16x12mm, 0°, 24mm Height
M555110091023Valeo Corpectomy 16x12mm, 0°, 23mm Height
M555110091022Valeo Corpectomy 16x12mm, 0°, 22mm Height
M555110091021Valeo Corpectomy 16x12mm, 0°, 21mm Height
M555110091020Valeo Corpectomy 16x12mm, 0°, 20mm Height
M555110091019Valeo Corpectomy 16x12mm, 0°, 19mm Height
M555110091018Valeo Corpectomy 16x12mm, 0°, 18mm Height
M555110091017Valeo Corpectomy 16x12mm, 0°, 17mm Height
M555110091016Valeo Corpectomy 16x12mm, 0°, 16mm Height
M555110091015Valeo Corpectomy 16x12mm, 0°, 15mm Height
M555110091014Valeo Corpectomy 16x12mm, 0°, 14mm Height
M555110091013Valeo Corpectomy 16x12mm, 0°, 13mm Height
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.