Convex Cage, 32 x 8mm

GUDID M739FPC32080

Convex Cage, 32 x 8mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM739FPC32080
NIH Device Record Keyb01e587f-1f03-4b19-bdec-77018897ce36
Commercial Distribution StatusIn Commercial Distribution
Brand NameConvex Cage, 32 x 8mm
Version Model NumberFPC3208
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
HIBCCM739FPC32080 [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

[M739FPC32080]

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, 32 x 8mm ]

M739FPC32080Convex Cage, 32 x 8mm
M739FPC3208Convex Cage, 32 x 8mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.