TirboLOX-L Lumbar IBFD

GUDID M7391916922100

3D Lordotic 6° Cage 22mm x 9.5mm x 10mm

CAPTIVA SPINE, INC.

Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere Spinal fusion sphere
Primary Device IDM7391916922100
NIH Device Record Key2b7fec8f-0587-46f2-bc13-ec826de5b443
Commercial Distribution StatusIn Commercial Distribution
Brand NameTirboLOX-L Lumbar IBFD
Version Model Number19169-2210
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
Device Count1
DM Exempttrue
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

Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7391916922100 [Primary]
HIBCCM7391916922100 [Primary]
HIBCCM7391916922100 [Primary]
HIBCCM7391916922100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7391916922100]

Radiation Sterilization


[M7391916922100]

Radiation Sterilization


[M7391916922100]

Radiation Sterilization


[M7391916922100]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [TirboLOX-L Lumbar IBFD]

M7391910925140Titanium convex lumbar cage 9.5mm W x 25mm L x 14mm H
M7391910925130Titanium convex lumbar cage 9.5mm W x 25mm L x 13mm H
M7391910925120Titanium convex lumbar cage 9.5mm W x 25mm L x 12mm H
M7391910925110Titanium convex lumbar cage 9.5mm W x 25mm L x 11mm H
M7391910925100Titanium convex lumbar cage 9.5mm W x 25mm L x 10mm H
M7391910925090Titanium convex lumbar cage 9.5mm W x 25mm L x 9mm H
M7391910925080Titanium convex lumbar cage 9.5mm W x 25mm L x 8mm H
M7391910925070Titanium convex lumbar cage 9.5mm W x 25mm L x 7mm H
M7391910922140Titanium lordotic lumbar cage 9.5mm W x 22mm L x 14mm H
M7391910922130Titanium lordotic lumbar cage 9.5mm W x 22mm L x 13mm H
M7391910922120Titanium lordotic lumbar cage 9.5mm W x 22mm L x 12mm H
M7391910922110Titanium lordotic lumbar cage 9.5mm W x 22mm L x 11mm H
M7391910922100Titanium lordotic lumbar cage 9.5mm W x 22mm L x 10mm H
M7391910922090Titanium lordotic lumbar cage 9.5mm W x 22mm L x 9mm H
M7391910922080Titanium lordotic lumbar cage 9.5mm W x 22mm L x 8mm H
M7391910922070Titanium lordotic lumbar cage 9.5mm W x 22mm L x 7mm H
M7391910630140Titanium lordotic lumbar cage 9.5mm W x 30mm L x 14mm H
M7391910630130Titanium lordotic lumbar cage 9.5mm W x 30mm L x 13mm H
M7391910630120Titanium lordotic lumbar cage 9.5mm W x 30mm L x 12mm H
M7391910630110Titanium lordotic lumbar cage 9.5mm W x 30mm L x 11mm H
M7391910630100Titanium lordotic lumbar cage 9.5mm W x 30mm L x 10mm H
M7391910630090Titanium lordotic lumbar cage 9.5mm W x 30mm L x 9mm H
M7391910630080Titanium lordotic lumbar cage 9.5mm W x 30mm L x 8mm H
M73919111251003D Straight Cage 25 x 10mm
M73919111250903D Straight Cage 25 x 9mm
M73919111250803D Straight Cage 25 x 8mm
M73919111361603D Straight Cage 36 x 16mm
M73919111361503D Straight Cage 36 x 15mm
M73919111361403D Straight Cage 36 x 14mm
M73919111361303D Straight Cage 36 x 13mm
M73919111361203D Straight Cage 36 x 12mm
M73919111361103D Straight Cage 36 x 11mm
M73919111361003D Straight Cage 36 x 10mm
M73919111360903D Straight Cage 36 x 9mm
M73919111360803D Straight Cage 36 x 8mm
M73919111341603D Straight Cage 34 x 16mm
M73919111341503D Straight Cage 34 x 15mm
M73919111341403D Straight Cage 34 x 14mm
M73919111341303D Straight Cage 34 x 13mm
M73919111341203D Straight Cage 34 x 12mm
M73919111341103D Straight Cage 34 x 11mm
M73919111341003D Straight Cage 34 x 10mm
M73919111340903D Straight Cage 34 x 9mm
M73919111340803D Straight Cage 34 x 8mm
M73919111321603D Straight Cage 32 x 16mm
M73919111321503D Straight Cage 32 x 15mm
M73919111321403D Straight Cage 32 x 14mm
M73919111321303D Straight Cage 32 x 13mm
M73919111321203D Straight Cage 32 x 12mm
M73919111321103D Straight Cage 32 x 11mm

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