SeaSpine Spacer System - Ventura NanoMetalene 33-6318-S

GUDID 00889981049884

Ventura NM Sterile Implant, 11mm x 32mm x 18mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis
Primary Device ID00889981049884
NIH Device Record Key09a75fca-258b-466a-89ba-5379f69f67c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeaSpine Spacer System - Ventura NanoMetalene
Version Model Number33-6318-S
Catalog Number33-6318-S
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
GS100889981049884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-11-02

On-Brand Devices [SeaSpine Spacer System - Ventura NanoMetalene]

00889981120088Ventura NM Sterile Implant, 9mm x 32mm x 7mm
00889981050125Ventura NM Sterile Implant, 11mm x 28mm x 18mm
00889981050118Ventura NM Sterile Implant, 11mm x 28mm x 17mm
00889981050101Ventura NM Sterile Implant, 11mm x 28mm x 16mm
00889981050095Ventura NM Sterile Implant, 11mm x 28mm x 15mm
00889981050088Ventura NM Sterile Implant, 11mm x 28mm x 14mm
00889981050071Ventura NM Sterile Implant, 11mm x 28mm x 13mm
00889981050064Ventura NM Sterile Implant, 11mm x 28mm x 12mm
00889981050057Ventura NM Sterile Implant, 11mm x 28mm x 11mm
00889981050040Ventura NM Sterile Implant, 11mm x 28mm x 10mm
00889981050033Ventura NM Sterile Implant, 11mm x 28mm x 9mm
00889981050026Ventura NM Sterile Implant, 11mm x 28mm x 8mm
00889981050019Ventura NM Sterile Implant, 11mm x 28mm x 7mm
00889981050002Ventura NM Sterile Implant, 9mm x 28mm x 18mm
00889981049990Ventura NM Sterile Implant, 9mm x 28mm x 17mm
00889981049983Ventura NM Sterile Implant, 9mm x 28mm x 16mm
00889981049976Ventura NM Sterile Implant, 9mm x 28mm x 15mm
00889981049969Ventura NM Sterile Implant, 9mm x 28mm x 14mm
00889981049952Ventura NM Sterile Implant, 9mm x 28mm x 13mm
00889981049945Ventura NM Sterile Implant, 9mm x 28mm x 12mm
00889981049938Ventura NM Sterile Implant, 9mm x 28mm x 11mm
00889981049921Ventura NM Sterile Implant, 9mm x 28mm x 10mm
00889981049914Ventura NM Sterile Implant, 9mm x 28mm x 9mm
00889981049907Ventura NM Sterile Implant, 9mm x 28mm x 8mm
00889981049891Ventura NM Sterile Implant, 9mm x 28mm x 7mm
00889981049884Ventura NM Sterile Implant, 11mm x 32mm x 18mm
00889981049877Ventura NM Sterile Implant, 11mm x 32mm x 17mm
00889981049860Ventura NM Sterile Implant, 11mm x 32mm x 16mm
00889981049853Ventura NM Sterile Implant, 11mm x 32mm x 15mm
00889981049846Ventura NM Sterile Implant, 11mm x 32mm x 14mm
00889981049839Ventura NM Sterile Implant, 11mm x 32mm x 13mm
00889981049822Ventura NM Sterile Implant, 11mm x 32mm x 12mm
00889981049815Ventura NM Sterile Implant, 11mm x 32mm x 11mm
00889981049808Ventura NM Sterile Implant, 11mm x 32mm x 10mm
00889981049792Ventura NM Sterile Implant, 11mm x 32mm x 9mm
00889981049785Ventura NM Sterile Implant, 11mm x 32mm x 8mm
00889981049778Ventura NM Sterile Implant, 11mm x 32mm x 7mm
00889981049761Ventura NM Sterile Implant, 9mm x 32mm x 18mm
00889981049754Ventura NM Sterile Implant, 9mm x 32mm x 17mm
00889981049747Ventura NM Sterile Implant, 9mm x 32mm x 16mm
00889981049730Ventura NM Sterile Implant, 9mm x 32mm x 15mm
00889981049723Ventura NM Sterile Implant, 9mm x 32mm x 14mm
00889981049716Ventura NM Sterile Implant, 9mm x 32mm x 13mm
00889981049709Ventura NM Sterile Implant, 9mm x 32mm x 12mm
00889981049693Ventura NM Sterile Implant, 9mm x 32mm x 11mm
00889981049686Ventura NM Sterile Implant, 9mm x 32mm x 10mm
00889981049679Ventura NM Sterile Implant, 9mm x 32mm x 9mm
00889981049662Ventura NM Sterile Implant, 9mm x 32mm x 8mm

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