ClariVy™

GUDID 00840283400032

IBF, Sterile, 14x11, 0°, 5mm, PEEK Optima LT1-HA

VY SPINE LLC

Polymeric spinal interbody fusion cage
Primary Device ID00840283400032
NIH Device Record Key30706071-34bb-4728-959b-07cb4d76498e
Commercial Distribution StatusIn Commercial Distribution
Brand NameClariVy™
Version Model Number02-C-1411-0-05-PH-R
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 Datetrue
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
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
GS100840283400032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-14
Device Publish Date2023-01-06

On-Brand Devices [ClariVy™]

00840283400179IBF Rasp
00840283400162IBF Inserter
00840283400155IBF, Sterile, 14x11, 7°, 10mm, PEEK Optima LT1-HA
00840283400148IBF, Sterile, 14x11, 7°, 9mm, PEEK Optima LT1-HA
00840283400131IBF, Sterile, 14x11, 7°, 8mm, PEEK Optima LT1-HA
00840283400124IBF, Sterile, 14x11, 7°, 7mm, PEEK Optima LT1-HA
00840283400117IBF, Sterile, 14x11, 7°, 6mm, PEEK Optima LT1-HA
00840283400100IBF, Sterile, 14x11, 7°, 5mm, PEEK Optima LT1-HA
00840283400094IBF, Sterile, 14x11, 7°, 4mm, PEEK Optima LT1-HA
00840283400230IBF Trial, 12x10, 8mm
00840283400223IBF Trial, 12x10, 7mm
00840283400216IBF Trial, 12x10, 6mm
00840283400209IBF Trial, 12x10, 5mm
00840283400193IBF Trial, 12x10, 4mm
00840283400247IBF Trial, 12x10, 9mm
00840283400087IBF, Sterile, 14x11, 0°, 10mm, PEEK Optima LT1-HA
00840283400070IBF, Sterile, 14x11, 0°, 9mm, PEEK Optima LT1-HA
00840283400063IBF, Sterile, 14x11, 0°, 8mm, PEEK Optima LT1-HA
00840283400056IBF, Sterile, 14x11, 0°, 7mm, PEEK Optima LT1-HA
00840283400049IBF, Sterile, 14x11, 0°, 6mm, PEEK Optima LT1-HA
00840283400032IBF, Sterile, 14x11, 0°, 5mm, PEEK Optima LT1-HA
00840283400025IBF, Sterile, 14x11, 0°, 4mm, PEEK Optima LT1-HA
00840283400278IBF Trial, 14x11, 6mm
00840283400261IBF Trial, 14x11, 5mm
00840283400254IBF Trial, 14x11, 4mm
00840283400292IBF Trial, 14x11, 8mm
00840283400285IBF Trial, 14x11, 7mm
00840283400308IBF Trial, 14x11, 9mm
00840283405259OsteoVy™ PEKK IBF, Sterile, 12x10, 7°, 8mm, OXPEKK IG100
00840283405242OsteoVy™ PEKK IBF, Sterile, 12x10, 7°, 7mm, OXPEKK IG100
00840283401237IBF Trial, 14x11 / 16x14
00840283404283OsteoVy™ PEKK IBF, Sterile, 14x11, 0°, 8mm, OXPEKK IG100
00840283404276OsteoVy™ PEKK IBF, Sterile, 14x11, 0°, 7mm, OXPEKK IG100
00840283404269OsteoVy™ PEKK IBF, Sterile, 14x11, 0°, 6mm, OXPEKK IG100
00840283404252OsteoVy™ PEKK IBF, Sterile, 14x11, 0°, 5mm, OXPEKK IG100
00840283404245OsteoVy™ PEKK IBF, Sterile, 14x11, 0°, 4mm, OXPEKK IG100
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