TLIF Curved-L, 36 x 13mm

GUDID M739PL36130

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739PL36130
NIH Device Record Key9044d93c-ede7-4601-8253-5da3724d6c55
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLIF Curved-L, 36 x 13mm
Version Model NumberPL3613
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
HIBCCM739PL36130 [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

[M739PL36130]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-08-11

On-Brand Devices [TLIF Curved-L, 36 x 13mm]

M739PL36130PL3613
M739PL3613TLIF Curved-L, 36 x 13mm

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