FuseLOX Cervical Inserter Shaft

GUDID M739FCI0200

FuseLOX Cervical Inserter Shaft

CAPTIVA SPINE, INC.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device IDM739FCI0200
NIH Device Record Keye6389656-f4fa-4062-9858-2780bf9fe637
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuseLOX Cervical Inserter Shaft
Version Model NumberFCI0200
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM739FCI0200 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


[M739FCI0200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-23
Device Publish Date2025-06-13

Devices Manufactured by CAPTIVA SPINE, INC.

M739FCI0200 - FuseLOX Cervical Inserter Shaft2025-06-23FuseLOX Cervical Inserter Shaft
M739FCI0200 - FuseLOX Cervical Inserter Shaft2025-06-23 FuseLOX Cervical Inserter Shaft
M739161554030 - MIS Curved Rod, Ø5.5 x 30mm2025-05-28 MIS Curved Rod
M739161554035 - MIS Curved Rod, Ø5.5 x 35mm2025-05-28 MIS Curved Rod
M739161554040 - MIS Curved Rod, Ø5.5 x 40mm2025-05-28 MIS Curved Rod
M739161554045 - MIS Curved Rod, Ø5.5 x 45mm2025-05-28 MIS Curved Rod
M739161554050 - MIS Curved Rod, Ø5.5 x 50mm2025-05-28 MIS Curved Rod
M739161554055 - MIS Curved Rod, Ø5.5 x 55mm2025-05-28 MIS Curved Rod
M739161554060 - MIS Curved Rod, Ø5.5 x 60mm2025-05-28 MIS Curved Rod

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.