TLIF Straight, 28 x 15mm

GUDID M739PS28150

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739PS28150
NIH Device Record Keyd4ed2321-ed85-46a4-8aba-848d020f7401
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLIF Straight, 28 x 15mm
Version Model NumberPS2815
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
HIBCCM739PS28150 [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

[M739PS28150]

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 15mm]

M739PS28150PS2815
M739PS2815TLIF Straight, 28 x 15mm

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