VyPlate™

GUDID 00840283402067

Two-Level Plate, 44mm, Ti 6Al-4V

VY SPINE LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840283402067
NIH Device Record Key6d49735b-3d39-4772-8046-fe1455684880
Commercial Distribution StatusIn Commercial Distribution
Brand NameVyPlate™
Version Model Number06-P2-44-TI-N
Company DUNS049592888
Company NameVY SPINE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com
Phone866-489-7746
Emailinfo@vyspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840283402067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


[00840283402067]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-29
Device Publish Date2025-09-26

On-Brand Devices [VyPlate™]

00840283402081Two-Level Plate, 52mm, Ti 6Al-4V
00840283402067Two-Level Plate, 44mm, Ti 6Al-4V
00840283402050Two-Level Plate, 40mm, Ti 6Al-4V
00840283402043Two-Level Plate, 36mm, Ti 6Al-4V
00840283402036Two-Level Plate, 32mm, Ti 6Al-4V
00840283402012Two-Level Plate, 24mm, Ti 6Al-4V
00840283402005Single-Level Plate, 26mm, Ti 6Al-4V
00840283401978Single-Level Plate, 20mm, Ti 6Al-4V
00840283401961Single-Level Plate, 18mm, Ti 6Al-4V
00840283401954Single-Level Plate, 16mm, Ti 6Al-4V
00840283401725Drilling, Variable Screw, Ø4.0x12mm, Ti 6Al-4V
00840283405839Single-Level Plate, 10mm, Ti 6Al-4V
00840283401664Threaded Fixation Pin

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