TLIF Curved-L, 36 x 11mm

GUDID M739PL3611

TLIF Curved-L, 36 x 11mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739PL3611
NIH Device Record Key6275fd2c-d44c-46b0-83e7-f4b8b5a636e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLIF Curved-L, 36 x 11mm
Version Model NumberPL3611
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
HIBCCM739PL3611 [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

[M739PL3611]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-08-28

On-Brand Devices [TLIF Curved-L, 36 x 11mm]

M739PL36110PL3611
M739PL3611TLIF Curved-L, 36 x 11mm

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