SeaSpine Spacer System - Ventura™ NanoMetalene® 93-3827

GUDID 10889981050283

Ventura NM Trial, 9mm x 28mm x 14mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

Primary Device ID	10889981050283
NIH Device Record Key	c18d166f-f64d-4177-8dff-f9676086dc5a
Commercial Distribution Status	In Commercial Distribution
Brand Name	SeaSpine Spacer System - Ventura™ NanoMetalene®
Version Model Number	93-3827
Catalog Number	93-3827
Company DUNS	079840876
Company Name	SEASPINE ORTHOPEDICS CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981050283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142488

FDA Product Code

ODP	Intervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10889981050283]

Moist Heat or Steam Sterilization

[10889981050283]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-07
Device Publish Date	2015-09-24

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

10889981050696	Ventura NM Instrument Tray
10889981050689	Ventura NM Trial, 11mm x 32mm x 18mm
10889981050672	Ventura NM Trial, 11mm x 32mm x 17mm
10889981050665	Ventura NM Trial, 11mm x 32mm x 16mm
10889981050658	Ventura NM Trial, 11mm x 32mm x 15mm
10889981050641	Ventura NM Trial, 11mm x 32mm x 14mm
10889981050634	Ventura NM Trial, 11mm x 32mm x 13mm
10889981050627	Ventura NM Trial, 11mm x 32mm x 12mm
10889981050610	Ventura NM Trial, 11mm x 32mm x 11mm
10889981050603	Ventura NM Trial, 11mm x 32mm x 10mm
10889981050597	Ventura NM Trial, 11mm x 32mm x 9mm
10889981050580	Ventura NM Trial, 11mm x 32mm x 8mm
10889981050573	Ventura NM Trial, 11mm x 32mm x 7mm
10889981050566	Ventura NM Trial, 9mm x 32mm x 18mm
10889981050559	Ventura NM Trial, 9mm x 32mm x 17mm
10889981050542	Ventura NM Trial, 9mm x 32mm x 16mm
10889981050535	Ventura NM Trial, 9mm x 32mm x 15mm
10889981050528	Ventura NM Trial, 9mm x 32mm x 14mm
10889981050511	Ventura NM Trial, 9mm x 32mm x 13mm
10889981050504	Ventura NM Trial, 9mm x 32mm x 12mm
10889981050498	Ventura NM Trial, 9mm x 32mm x 11mm
10889981050481	Ventura NM Trial, 9mm x 32mm x 10mm
10889981050474	Ventura NM Trial, 9mm x 32mm x 9mm
10889981050467	Ventura NM Trial, 9mm x 32mm x 8mm
10889981050450	Ventura NM Trial, 9mm x 32mm x 7mm
10889981050443	Ventura NM Trial, 11mm x 28mm x 18mm
10889981050436	Ventura NM Trial, 11mm x 28mm x 17mm
10889981050429	Ventura NM Trial, 11mm x 28mm x 16mm
10889981050412	Ventura NM Trial, 11mm x 28mm x 15mm
10889981050405	Ventura NM Trial, 11mm x 28mm x 14mm
10889981050399	Ventura NM Trial, 11mm x 28mm x 13mm
10889981050382	Ventura NM Trial, 11mm x 28mm x 12mm
10889981050375	Ventura NM Trial, 11mm x 28mm x 11mm
10889981050368	Ventura NM Trial, 11mm x 28mm x 10mm
10889981050351	Ventura NM Trial, 11mm x 28mm x 9mm
10889981050344	Ventura NM Trial, 11mm x 28mm x 8mm
10889981050337	Ventura NM Trial, 11mm x 28mm x 7mm
10889981050320	Ventura NM Trial, 9mm x 28mm x 18mm
10889981050313	Ventura NM Trial, 9mm x 28mm x 17mm
10889981050306	Ventura NM Trial, 9mm x 28mm x 16mm
10889981050290	Ventura NM Trial, 9mm x 28mm x 15mm
10889981050283	Ventura NM Trial, 9mm x 28mm x 14mm
10889981050276	Ventura NM Trial, 9mm x 28mm x 13mm
10889981050269	Ventura NM Trial, 9mm x 28mm x 12mm
10889981050252	Ventura NM Trial, 9mm x 28mm x 11mm
10889981050245	Ventura NM Trial, 9mm x 28mm x 10mm
10889981050238	Ventura NM Trial, 9mm x 28mm x 9mm
10889981050221	Ventura NM Trial, 9mm x 28mm x 8mm
10889981050214	Ventura NM Trial, 9mm x 28mm x 7mm
10889981050207	Ventura NM Instrument Tray