TLIF Straight, 28 x 12mm

GUDID M739PS28120

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739PS28120
NIH Device Record Key43f2ad8a-18a9-4cec-a4ab-e2259ebde335
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLIF Straight, 28 x 12mm
Version Model NumberPS2812
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
HIBCCM739PS28120 [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

[M739PS28120]

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, 28 x 12mm]

M739PS28120PS2812
M739PS2812TLIF Straight, 28 x 12mm

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