TLIF Straight, 28 x 16mm

GUDID M739PS2816

TLIF Straight, 28 x 16mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739PS2816
NIH Device Record Keya3fe3c2a-ec24-49da-b2ac-59fe6fcc6f37
Commercial Distribution Discontinuation2017-08-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTLIF Straight, 28 x 16mm
Version Model NumberPS2816
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
HIBCCM739PS2816 [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

[M739PS2816]

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 Straight, 28 x 16mm]

M739PS28160PS2816
M739PS2816TLIF Straight, 28 x 16mm

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