Lordotic Cage, 12 x 7mm

GUDID M739FCL12070

Lordotic Cage, 12 x 7mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739FCL12070
NIH Device Record Key6f45c1f6-d091-435c-925b-86a9f1cd76e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLordotic Cage, 12 x 7mm
Version Model NumberFCL1207
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
HIBCCM739FCL12070 [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

[M739FCL12070]

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 7mm]

M739FCL12070Lordotic Cage, 12 x 7mm
M739FCL1207Lordotic Cage, 12 x 7mm

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