Lordotic Cage, 12 x 5mm

GUDID M739FCL12050

Lordotic Cage, 12 x 5mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739FCL12050
NIH Device Record Keye7a0ad37-87ad-4c55-bb9a-cb0fe027ee5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLordotic Cage, 12 x 5mm
Version Model NumberFCL1205
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
HIBCCM739FCL12050 [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

[M739FCL12050]

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 5mm]

M739FCL12050Lordotic Cage, 12 x 5mm
M739FCL1205Lordotic Cage, 12 x 5mm

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