Convex Cage, 28 x 13mm

GUDID M739FPC28130

Convex Cage, 28 x 13mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739FPC28130
NIH Device Record Keydf99d613-4bfc-4f50-a283-3ba5ca546583
Commercial Distribution StatusIn Commercial Distribution
Brand NameConvex Cage, 28 x 13mm
Version Model NumberFPC2813
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
HIBCCM739FPC28130 [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

[M739FPC28130]

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 [ Convex Cage, 28 x 13mm ]

M739FPC28130Convex Cage, 28 x 13mm
M739FPC2813Convex Cage, 28 x 13mm

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