Cambria NanoMetalene 39-2811-S

GUDID 00889981065044

Cambria NM Implant,17 x 13 x 11mm,Lordotic,Sterile

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis
Primary Device ID00889981065044
NIH Device Record Keyd825d6fc-e663-4f32-b599-9a8e7e9ab93e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCambria NanoMetalene
Version Model Number39-2811-S
Catalog Number39-2811-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
GS100889981065044 [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 [Cambria NanoMetalene]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.