Vu a POD Prime NanoMetalene 35-14-1625

GUDID 10889981159566

Prime NM Implant, 31x24mm x 16mm, 25 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis
Primary Device ID10889981159566
NIH Device Record Key1808d54a-0b08-44b6-823c-6267d5aca552
Commercial Distribution StatusIn Commercial Distribution
Brand NameVu a POD Prime NanoMetalene
Version Model Number35-14-1625
Catalog Number35-14-1625
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS 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

Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981159566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-06-12

On-Brand Devices [Vu a POD Prime NanoMetalene]

10889981160128Prime NM Implant, 43x30mm x 18mm, 25 Deg
10889981159665Prime NM Implant, 43x30mm x 16mm, 25 Deg
10889981159658Prime NM Implant, 39x30mm x 18mm, 25 Deg
10889981159641Prime NM Implant, 39x30mm x 16mm, 25 Deg
10889981159634Prime NM Implant, 39x27mm x 18mm, 25 Deg
10889981159627Prime NM Implant, 39x27mm x 16mm, 25 Deg
10889981159610Prime NM Implant, 39x27mm x 14mm, 25 Deg
10889981159603Prime NM Implant, 35x27mm x 18mm, 25 Deg
10889981159597Prime NM Implant, 35x27mm x 16mm, 25 Deg
10889981159580Prime NM Implant, 35x27mm x 14mm, 25 Deg
10889981159573Prime NM Implant, 31x24mm x 18mm, 25 Deg
10889981159566Prime NM Implant, 31x24mm x 16mm, 25 Deg
10889981159559Prime NM Implant, 31x24mm x 14mm, 25 Deg

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