Ventura NanoMetalene System 93-3751

GUDID 10889981152055

Ventura NM Trial, 9mm x 28mm x 12mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

Primary Device ID	10889981152055
NIH Device Record Key	19956072-dfdb-46e4-9e12-036e18ff325a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ventura NanoMetalene System
Version Model Number	93-3751
Catalog Number	93-3751
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	10889981152055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173022

FDA Product Code

MAX	Intervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10889981152055]

Moist Heat or Steam Sterilization

[10889981152055]

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	2017-11-17

On-Brand Devices [Ventura NanoMetalene System]

10889981152291	Ventura NM Trial, 11mm x 32mm x 17mm, Lordotic
10889981152284	Ventura NM Trial, 11mm x 32mm x 16mm, Lordotic
10889981152277	Ventura NM Trial, 11mm x 32mm x 15mm, Lordotic
10889981152260	Ventura NM Trial, 11mm x 32mm x 14mm, Lordotic
10889981152253	Ventura NM Trial, 11mm x 32mm x 13mm, Lordotic
10889981152246	Ventura NM Trial, 11mm x 32mm x 12mm, Lordotic
10889981152239	Ventura NM Trial, 11mm x 32mm x 11mm, Lordotic
10889981152222	Ventura NM Trial, 11mm x 32mm x 10mm, Lordotic
10889981152215	Ventura NM Trial, 11mm x 32mm x 09mm, Lordotic
10889981152208	Ventura NM Trial, 11mm x 28mm x 17mm, Lordotic
10889981152192	Ventura NM Trial, 11mm x 28mm x 16mm, Lordotic
10889981152185	Ventura NM Trial, 11mm x 28mm x 15mm, Lordotic
10889981152178	Ventura NM Trial, 11mm x 28mm x 14mm, Lordotic
10889981152161	Ventura NM Trial, 11mm x 28mm x 13mm, Lordotic
10889981152154	Ventura NM Trial, 11mm x 28mm x 12mm, Lordotic
10889981152147	Ventura NM Trial, 11mm x 28mm x 11mm, Lordotic
10889981152130	Ventura NM Trial, 11mm x 28mm x 10mm, Lordotic
10889981152123	Ventura NM Trial, 11mm x 28mm x 09mm, Lordotic
10889981152116	Ventura NM Trial, 11mm x 28mm x 08mm, Lordotic
10889981152109	Ventura NM Trial, 9mm x 28mm x 17mm, Lordotic
10889981152093	Ventura NM Trial, 9mm x 28mm x 16mm, Lordotic
10889981152086	Ventura NM Trial, 9mm x 28mm x 15mm, Lordotic
10889981152079	Ventura NM Trial, 9mm x 28mm x 14mm, Lordotic
10889981152062	Ventura NM Trial, 9mm x 28mm x 13mm, Lordotic
10889981152055	Ventura NM Trial, 9mm x 28mm x 12mm, Lordotic
10889981152048	Ventura NM Trial, 9mm x 28mm x 11mm, Lordotic
10889981152031	Ventura NM Trial, 9mm x 28mm x 10mm, Lordotic
10889981152024	Ventura NM Trial, 9mm x 28mm x 9mm, Lordotic
10889981152017	Ventura NM Trial, 9mm x 28mm x 8mm, Lordotic
10889981152000	Ventura NM Trial, 11mm x 24mm x 17mm, Lordotic
10889981151997	Ventura NM Trial, 11mm x 24mm x 16mm, Lordotic
10889981151980	Ventura NM Trial, 11mm x 24mm x 15mm, Lordotic
10889981151973	Ventura NM Trial, 11mm x 24mm x 14mm, Lordotic
10889981151966	Ventura NM Trial, 11mm x 24mm x 13mm, Lordotic
10889981151959	Ventura NM Trial, 11mm x 24mm x 12mm, Lordotic
10889981151942	Ventura NM Trial, 11mm x 24mm x 11mm, Lordotic
10889981151935	Ventura NM Trial, 11mm x 24mm x 10mm, Lordotic
10889981151928	Ventura NM Trial, 11mm x 24mm x 09mm, Lordotic
10889981151911	Ventura NM Trial, 11mm x 24mm x 08mm, Lordotic
10889981151904	Ventura NM Trial, 9mm x 24mm x 17mm, Lordotic
10889981151898	Ventura NM Trial, 9mm x 24mm x 16mm, Lordotic
10889981151881	Ventura NM Trial, 9mm x 24mm x 15mm, Lordotic
10889981151874	Ventura NM Trial, 9mm x 24mm x 14mm, Lordotic
10889981151867	Ventura NM Trial, 9mm x 24mm x 13mm, Lordotic
10889981151850	Ventura NM Trial, 9mm x 24mm x 12mm, Lordotic
10889981151843	Ventura NM Trial, 9mm x 24mm x 11mm, Lordotic
10889981151836	Ventura NM Trial, 9mm x 24mm x 10mm, Lordotic
10889981151829	Ventura NM Trial, 9mm x 24mm x 9mm, Lordotic
10889981151812	Ventura NM Trial, 9mm x 24mm x 8mm, Lordotic
10889981151805	Ventura NM Trial, 11mm x 24mm x 17mm