TLIF Straight, 32 x 16mm

GUDID M739PS32160

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739PS32160
NIH Device Record Key9a5ad818-7b6c-40ed-88fd-93f592718088
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLIF Straight, 32 x 16mm
Version Model NumberPS3216
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
HIBCCM739PS32160 [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

[M739PS32160]

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 Straight, 32 x 16mm]

M739PS32160PS3216
M739PS3216TLIF Straight, 32 x 16mm

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