Vu aPod™ - L 31-23-1250-12

GUDID 10889981046705

LATERAL IMPLANT, LORDOTIC, 12mm X 23mm X 50mm X 12°

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile
Primary Device ID10889981046705
NIH Device Record Keyed8fef0c-9f97-440a-bd34-87f2dea5b3a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVu aPod™ - L
Version Model Number31-23-1250-12
Catalog Number31-23-1250-12
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
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
GS110889981046705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981046705]

Moist Heat or Steam Sterilization

[10889981046705]

Moist Heat or Steam Sterilization

[10889981046705]

Moist Heat or Steam Sterilization

[10889981046705]

Moist Heat or Steam Sterilization

[10889981046705]

Moist Heat or Steam Sterilization

[10889981046705]

Moist Heat or Steam Sterilization

[10889981046705]

Moist Heat or Steam Sterilization

[10889981046705]

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 aPod™ - L]

10889981121501Trial Extractor, 8mm Lordotic
10889981121495Angled Draw Rod Assembly, 6-32, 8mm Lordotic
10889981121488SPINPLATE Snap Assist Tool
10889981121471Graft Block
10889981118150Vu aPod-L Instrument Case
10889981118143Lordotic Wide Implant Caddy, 60mm
10889981118136Wide Lordotic Implant Caddy, 55mm
10889981118129Wide Lordotic Implant Caddy, 50mm
10889981118112Wide Lordotic Implant Caddy, 45mm
10889981118105Wide Lordotic Implant Caddy, 40mm
10889981118099Wide Standard Implant Caddy, 60mm
10889981118082Wide Standard Implant Caddy, 55mm
10889981118075Wide Standard Implant Caddy, 50mm
10889981118068Wide Standard Implant Caddy, 45mm
10889981118051Wide Standard Implant Caddy, 40mm
10889981118044Vu aPod-L Wide Implant Case
10889981118037Narrow Lordotic Implant Caddy, 60mm
10889981118020Narrow Lordotic Implant Caddy, 55mm
10889981118013Narrow Lordotic Implant Caddy, 50mm
10889981118006Narrow Lordotic Implant Caddy, 45mm
10889981117993Narrow Lordotic Implant Caddy, 40mm
10889981117986Narrow Standard Implant Caddy, 60mm
10889981117979Narrow Standard Implant Caddy, 55mm
10889981117962Narrow Standard Implant Caddy, 50mm
10889981117955Narrow Standard Implant Caddy, 45mm
10889981117948Narrow Standard Implant Caddy, 40mm
10889981117931Vu aPod-L Narrow Implant Case
10889981117924Trial Extractor, Standard
10889981117917Angled Draw Rod Assembly, 12-28, Standard
10889981117900Angled Lateral Inserter Housing, RH
10889981117894Angled Lateral Inserter Housing, LH
10889981117887SPINPLATE Locker
10889981117870Lateral implant insertion slide
10889981117863Implant Slides
10889981097776Graft Tamp
10889981097738Slotted Mallet, .255
10889981097721Hudson Silicone Handle
10889981062422Vu aPod-L W Implant
10889981062415Vu aPod-L Narrow Implant
10889981062408Vu-aPOD-L 60mm Wide Optional Implant Caddy
10889981062392Vu-aPOD-L 60mm Narrow Optional Implant Caddy
10889981062385Vu-aPOD-L 45mm Wide Optional Implant Caddy
10889981062378Vu-aPOD-L 45mm Narrow Optional Implant Caddy
10889981062361Vu-aPOD-L 40mm Narrow Optional Implant Caddy
10889981062354Vu aPOD-L instrument
10889981062347Vu-aPOD-L 50 mm-55 mm Wide w-SpinPlate Implant Cad
10889981048167LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 60mm X 10°
10889981048150LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 55mm X 10°
10889981048143LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 50mm X 10°
10889981048136LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 45mm X 10°
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