SeaSpine Spacer System - Ventura NanoMetalene 33-6313-S

GUDID 00889981049839

Ventura NM Sterile Implant, 11mm x 32mm x 13mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

Primary Device ID	00889981049839
NIH Device Record Key	e5aa0c05-fb9f-4360-9570-9db7c3e43da4
Commercial Distribution Status	In Commercial Distribution
Brand Name	SeaSpine Spacer System - Ventura NanoMetalene
Version Model Number	33-6313-S
Catalog Number	33-6313-S
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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

Device Dimensions

Device Size Text, specify

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889981049839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162715

FDA Product Code

MAX	Intervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-02-24
Device Publish Date	2016-11-02

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

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