Lordotic Cage, 12 x 11mm

GUDID M739FCL12110

Lordotic Cage, 12 x 11mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739FCL12110
NIH Device Record Key86583eb5-72df-4227-9684-b0fc535325c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLordotic Cage, 12 x 11mm
Version Model NumberFCL1211
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM739FCL12110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M739FCL12110]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-07-21

On-Brand Devices [Lordotic Cage, 12 x 11mm]

M739FCL12110Lordotic Cage, 12 x 11mm
M739FCL1211Lordotic Cage, 12 x 11mm

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