Vu a-POD Prime NanoMetalene 33-29-3520

GUDID 10889981136987

Prime NM Trial, 35x27mm x 20mm 30 Deg

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial
Primary Device ID10889981136987
NIH Device Record Key7ce0f78a-c1a4-4935-a19a-c1250fc8a405
Commercial Distribution StatusIn Commercial Distribution
Brand NameVu a-POD Prime NanoMetalene
Version Model Number33-29-3520
Catalog Number33-29-3520
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 Datefalse
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981136987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981136987]

Moist Heat or Steam Sterilization


[10889981136987]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-12-06

On-Brand Devices [Vu a-POD Prime NanoMetalene]

10889981141097Implant Tray, Case
10889981141080Implant Tray, Lower Tray
10889981141073Implant Tray, Upper Tray
10889981140069Locking Screw Snap Ring
10889981140045Vu aPOD Prime NM Tray Lid
10889981139568Prime NM Implant, 43x30mm x 20mm 30 Deg
10889981139551Prime NM Implant, 43x30mm x 18mm 30 Deg
10889981139544Prime NM Implant, 43x30mm x 18mm 20 Deg
10889981139537Prime NM Implant, 43x30mm x 16mm 20 Deg
10889981139520Prime NM Implant, 43x30mm x 14mm 20 Deg
10889981139513Prime NM Implant, 39x27mm x 20mm, 30 Deg
10889981139506Prime NM Implant, 39x27mm x 18mm, 30 Deg
10889981139490Prime NM Implant, 39x27mm x 18mm, 20 Deg
10889981139483Prime NM Implant, 39x27mm x 16mm, 20 Deg
10889981139476Prime NM Implant, 39x27mm x 14mm, 20 Deg
10889981139469Prime NM Implant, 43x30mm x 16mm 15 Deg
10889981139452Prime NM Implant, 43x30mm x 14mm 15 Deg
10889981139445Prime NM Implant, 43x30mm x 12mm 15 Deg
10889981139438Prime NM Implant, 43x30mm x 16mm 10 Deg
10889981139421Prime NM Implant, 43x30mm x 14mm 10 Deg
10889981139414Prime NM Implant, 43x30mm x 12mm 10 Deg
10889981139407Prime NM Implant, 43x30mm x 10mm 10 Deg
10889981139391Prime NM Implant, 39x27mm x 16mm, 15 Deg
10889981139384Prime NM Implant, 39x27mm x 14mm, 15 Deg
10889981139377Prime NM Implant, 39x27mm x 12mm, 15 Deg
10889981139360Prime NM Implant, 39x27mm x 16mm, 10 Deg
10889981139353Prime NM Implant, 39x27mm x 14mm, 10 Deg
10889981139346Prime NM Implant, 39x27mm x 12mm, 10 Deg
10889981139339Prime NM Implant, 39x27mm x 10mm, 10 Deg
10889981139322Vu aPOD Prime NM Tray Lid
10889981139315Vu aPOD Prime NM Implant Trial Caddy
10889981139308Vu aPOD Prime NM Bone Screw Caddy
10889981139292Vu aPOD Prime NM Spin Plate Caddy
10889981139285Vu aPOD Prime NM Implant Case - Level 1
10889981139278Vu aPOD Prime NM Implant Case
10889981139261Vu aPOD Prime NM 20 and 30 Deg. Hyper Trial Caddy
10889981139254Vu aPOD Prime NM Instrument Case - Level 2
10889981139247Vu aPOD Prime NM Instrument Case - Level 1
10889981139230Vu aPOD Prime NM Instrument Case
10889981138486Prime NM Locking Screw, 6.5 Dia. X 35mm
10889981138479Prime NM Locking Screw, 6.5 Dia. X 27mm
10889981138462Prime NM Locking Screw, 6.0 Dia. X 35mm
10889981138455Prime NM Locking Screw, 6.0 Dia. X 27mm
10889981138448Prime NM Locking Screw, 5.5 Dia. X 35mm
10889981138431Prime NM Locking Screw, 5.5 Dia. X 30mm
10889981138424Prime NM Locking Screw, 5.5 Dia. X 27mm
10889981138417Prime NM Locking Screw, 5.5 Dia. X 25mm
10889981138400Prime NM Locking Screw, 5.5 Dia. X 20mm
1088998113812743X30MM Trial 16mm 25DEG
1088998113811043X30MM Trial 14mm 25DEG

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