Vu a-POD Prime™ 33-LT-3514

GUDID 10889981060800

35x27mm Implant 14mm 12 DEG

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile
Primary Device ID10889981060800
NIH Device Record Key2e473873-01ae-4758-ba3c-ed47816b3ec6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVu a-POD Prime™
Version Model Number33-LT-3514
Catalog Number33-LT-3514
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 Usefalse
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
GS110889981060800 [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

[10889981060800]

Moist Heat or Steam Sterilization

[10889981060800]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Vu a-POD Prime™]

1088998106125839x30mm Implant 18mm 8 deg.
1088998106124135x27mm Implant 18mm 15 deg.
1088998106123439x30mm Implant 18mm 15 Deg.
10889981061227Locking Screw 6.5x35mm
10889981061210Locking Screw 6.5x30mm
10889981061203Locking Screw 6.5x25mm
10889981061197Locking Screw 6.5x20mm
10889981061180Locking Screw 5.5x35mm
10889981061173Locking Screw 5.5x30mm
10889981061166Locking Screw 5.5x25mm
10889981061159Locking Screw 5.5x20mm
1088998106114235x27mm Implant 18mm 8 deg
1088998106113531x24mm Implant 18mm 8 deg
1088998106112835x27mm Implant 18mm 12 deg
1088998106111131x24mm Implant 18mm 12 deg
1088998106110439x30 Implant 16mm 15 Deg
1088998106109839x30 Implant 14mm 15 Deg
1088998106108139x30 Implant 12mm 15 Deg
1088998106107439x30 Implant 10mm 15 Deg
1088998106106735x27mm Implant 16mm 15 DEG
1088998106105035x27mm Implant 14mm 15 DEG
1088998106104335x27mm Implant 12mm 15 DEG
1088998106103635x27mm Implant 10mm 15 DEG
1088998106102931x24mm Implant 18mm 15 Deg
1088998106101231x24mm Implant 16mm 15 Deg
1088998106100531x24mm Implant 14mm 15 Deg
1088998106099231x24mm Implant 12mm 15 Deg
1088998106098531x24mm Implant 10mm 15 Deg
1088998106097839x27mm Implant 16mm 8 DEG
1088998106096139x27mm Implant 14mm 8 DEG
1088998106095439x27mm Implant 12mm 8 DEG
1088998106094739x27mm Implant 10mm 8 DEG
1088998106093035x27mm Implant 16mm 8 DEG
1088998106092335x27mm Implant 14mm 8 DEG
1088998106091635x27mm Implant 12mm 8 DEG
1088998106090935x27mm Implant 10mm 8 DEG
1088998106089331x24mm Implant 16mm 8 Deg
1088998106088631x24mm Implant 14mm 8 Deg
1088998106087931x24mm Implant 12mm 8 Deg
1088998106086231x24mm Implant 10mm 8 Deg
1088998106085539x27mm Implant 16mm 12 DEG
1088998106084839x27mm Implant 14mm 12 DEG
1088998106083139x27mm Implant 12mm 12 DEG
1088998106082439x27mm Implant 10mm 12 DEG
1088998106081735x27mm Implant 16mm 12 DEG
1088998106080035x27mm Implant 14mm 12 DEG
1088998106079435x27mm Implant 12mm 12 DEG
1088998106078735x27mm Implant 10mm 12 DEG
1088998106077031x24mm Implant 16mm 12 Deg
1088998106076331x24mm Implant 14mm 12 Deg
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.