Valeo Fusion System 11.004.1607

GUDID M555110041607

Valeo PL,9x21, 6°, 7mm

AMEDICA CORPORATION

Vertebral body prosthesis
Primary Device IDM555110041607
NIH Device Record Keya8bb2894-c78d-401e-bc01-ddbda9972987
Commercial Distribution StatusIn Commercial Distribution
Brand NameValeo Fusion System
Version Model NumberB
Catalog Number11.004.1607
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

Device Dimensions

Height7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM555110041607 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M555110041607]

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

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