Cambria NanoMetalene 39-2607-S

GUDID 00889981064924

Cambria NM Implant,15 x 13 x 7mm,Lordotic,Sterile

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

Primary Device ID	00889981064924
NIH Device Record Key	69a3bb79-24d9-4f13-9d1c-04323fa05992
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cambria NanoMetalene
Version Model Number	39-2607-S
Catalog Number	39-2607-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	00889981064924 [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 [Cambria NanoMetalene]

10889981137373	Cambria NM Implant, 17mm x 13mm x 12mm, Lordotic
10889981137366	Cambria NM Implant, 17mm x 13mm x 11mm, Lordotic
10889981137359	Cambria NM Implant, 17mm x 13mm x 10mm, Lordotic
10889981137342	Cambria NM Implant, 17mm x 13mm x 9mm, Lordotic
10889981137335	Cambria NM Implant, 17mm x 13mm x 8mm, Lordotic
10889981137328	Cambria NM Implant, 17mm x 13mm x 7mm, Lordotic
10889981137311	Cambria NM Implant, 17mm x 13mm x 6mm, Lordotic
10889981137304	Cambria NM Implant, 17mm x 13mm x 5mm, Lordotic
10889981137298	Cambria NM Implant, 15mm x 13mm x 12mm, Lordotic
10889981137281	Cambria NM Implant, 15mm x 13mm x 11mm, Lordotic
10889981137274	Cambria NM Implant, 15mm x 13mm x 10mm, Lordotic
10889981137267	Cambria NM Implant, 15mm x 13mm x 9mm, Lordotic
10889981137250	Cambria NM Implant, 15mm x 13mm x 8mm, Lordotic
10889981137243	Cambria NM Implant, 15mm x 13mm x 7mm, Lordotic
10889981137236	Cambria NM Implant, 15mm x 13mm x 6mm, Lordotic
10889981137229	Cambria NM Implant, 15mm x 13mm x 5mm, Lordotic
10889981120573	Cambria NM Sterilization Tray
10889981093839	Cambria NM Packing Block
10889981093822	Cambria NM Rasp
10889981093815	Cambria NM Graft Packer
10889981093808	Cambria NM Implant Tamp
00889981120118	Cambria NM Implant,13 x 12 x 12mm,Lordotic,Sterile
00889981065051	Cambria NM Implant,17 x 13 x 12mm,Lordotic,Sterile
00889981065044	Cambria NM Implant,17 x 13 x 11mm,Lordotic,Sterile
00889981065037	Cambria NM Implant,17 x 13 x 10mm,Lordotic,Sterile
00889981065020	Cambria NM Implant,17 x 13 x 9mm,Lordotic,Sterile
00889981065013	Cambria NM Implant,17 x 13 x 8mm,Lordotic,Sterile
00889981065006	Cambria NM Implant,17 x 13 x 7mm,Lordotic,Sterile
00889981064993	Cambria NM Implant,17 x 13 x 6mm,Lordotic,Sterile
00889981064986	Cambria NM Implant,17 x 13 x 5mm,Lordotic,Sterile
00889981064979	Cambria NM Implant,15 x 13 x 12mm,Lordotic,Sterile
00889981064962	Cambria NM Implant,15 x 13 x 11mm,Lordotic,Sterile
00889981064955	Cambria NM Implant,15 x 13 x 10mm,Lordotic,Sterile
00889981064948	Cambria NM Implant,15 x 13 x 9mm,Lordotic,Sterile
00889981064931	Cambria NM Implant,15 x 13 x 8mm,Lordotic,Sterile
00889981064924	Cambria NM Implant,15 x 13 x 7mm,Lordotic,Sterile
00889981064917	Cambria NM Implant,15 x 13 x 6mm,Lordotic,Sterile
00889981064900	Cambria NM Implant,15 x 13 x 5mm,Lordotic,Sterile
00889981064894	Cambria NM Implant,13 x 12 x 11mm,Lordotic,Sterile
00889981064887	Cambria NM Implant,13 x 12 x 10mm,Lordotic,Sterile
00889981064870	Cambria NM Implant,13 x 12 x 9mm,Lordotic,Sterile
00889981064863	Cambria NM Implant,13 x 12 x 8mm,Lordotic,Sterile
00889981064856	Cambria NM Implant,13 x 12 x 7mm,Lordotic,Sterile
00889981064849	Cambria NM Implant,13 x 12 x 6mm,Lordotic,Sterile
00889981064832	Cambria NM Implant,13 x 12 x 5mm,Lordotic,Sterile