SPIRA-O Open Matrix OLIF

GUDID B030SPO263208170

Bi-Convex 8° Lordotic, 26mm x 32mm, 17mm

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal fusion cage, non-sterile
Primary Device IDB030SPO263208170
NIH Device Record Keyeace9a70-640d-42ef-be18-a6ba8ca647f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPIRA-O Open Matrix OLIF
Version Model NumberSPO-2632-0817
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com

Device Dimensions

Width32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030SPO263208170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030SPO263208170]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-05
Device Publish Date2019-07-17

On-Brand Devices [ SPIRA-O Open Matrix OLIF]

B030SPO303820190Bi-Convex 20° Lordotic, 30mm x 38mm, 19mm
B030SPO303820170Bi-Convex 20° Lordotic, 30mm x 38mm, 17mm
B030SPO303820150Bi-Convex 20° Lordotic, 30mm x 38mm, 15mm
B030SPO303820130Bi-Convex 20° Lordotic, 30mm x 38mm, 13mm
B030SPO303815190Bi-Convex 15° Lordotic, 30mm x 38mm, 19mm
B030SPO303815170Bi-Convex 15° Lordotic, 30mm x 38mm, 17mm
B030SPO303815150Bi-Convex 15° Lordotic, 30mm x 38mm, 15mm
B030SPO303815130Bi-Convex 15° Lordotic, 30mm x 38mm, 13mm
B030SPO303815110Bi-Convex 15° Lordotic, 30mm x 38mm, 11mm
B030SPO303808190Bi-Convex 8° Lordotic, 30mm x 38mm, 19mm
B030SPO303808170Bi-Convex 8° Lordotic, 30mm x 38mm, 17mm
B030SPO303808150Bi-Convex 8° Lordotic, 30mm x 38mm, 15mm
B030SPO303808130Bi-Convex 8° Lordotic, 30mm x 38mm, 13mm
B030SPO303808110Bi-Convex 8° Lordotic, 30mm x 38mm, 11mm
B030SPO303808090Bi-Convex 8° Lordotic, 30mm x 38mm, 9mm
B030SPO263220170Bi-Convex 20° Lordotic, 26mm x 32mm, 17mm
B030SPO263220150Bi-Convex 20° Lordotic, 26mm x 32mm, 15mm
B030SPO263220130Bi-Convex 20° Lordotic, 26mm x 32mm, 13mm
B030SPO263220110Bi-Convex 20° Lordotic, 26mm x 32mm, 11mm
B030SPO263215170Bi-Convex 15° Lordotic, 26mm x 32mm, 17mm
B030SPO263215150Bi-Convex 15° Lordotic, 26mm x 32mm, 15mm
B030SPO263215130Bi-Convex 15° Lordotic, 26mm x 32mm, 13mm
B030SPO263215110Bi-Convex 15° Lordotic, 26mm x 32mm, 11mm
B030SPO263208170Bi-Convex 8° Lordotic, 26mm x 32mm, 17mm
B030SPO263208150Bi-Convex 8° Lordotic, 26mm x 32mm, 15mm
B030SPO263208130Bi-Convex 8° Lordotic, 26mm x 32mm, 13mm
B030SPO263208110Bi-Convex 8° Lordotic, 26mm x 32mm, 11mm
B030SPO263208090Bi-Convex 8° Lordotic, 26mm x 32mm, 9mm

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