Valeo Fusion System 91.009.9021

GUDID M555910099021

Amedica VBR Small Trial Caddy Assembly

AMEDICA CORPORATION

Internal spinal fixation procedure kit, single-use
Primary Device IDM555910099021
NIH Device Record Key8f3b8d66-4c47-402a-919b-d31f9d72077c
Commercial Distribution StatusIn Commercial Distribution
Brand NameValeo Fusion System
Version Model NumberA
Catalog Number91.009.9021
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone801-839-3500
Emailcustomerservice@amedica.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM555910099021 [Primary]

FDA Product Code

LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M555910099021]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-06-07
Device Publish Date2017-12-29

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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