Fixed Self-Drilling Screws, 4 mm x 12mm

GUDID M739ST16012

Fixed Self-Drilling Screws, 4 mm x 12mm

CAPTIVA SPINE, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device IDM739ST16012
NIH Device Record Keyee985fa6-662c-4302-83ef-2755c96d5244
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed Self-Drilling Screws, 4 mm x 12mm
Version Model NumberST16012
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
HIBCCM739ST16012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


[M739ST16012]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2015-10-30

Devices Manufactured by CAPTIVA SPINE, INC.

00850065741000 - EquiLOX Lumbar Expandable Cage - Bone Impactor2024-07-24 Bone impactor
00850065741017 - EquiLOX Lumbar Expandable Cage - Funnel2024-07-24 Funnel
00850065741024 - EquiLOX Lumbar Expandable Cage - Cage Holder (w retention rod)2024-07-24 Cage Holder (w retention rod)
00850065741031 - EquiLOX Lumbar Expandable Cage - Square Cage Driver2024-07-24 Square Cage Driver
00850065741048 - EquiLOX Lumbar Expandable Cage - Hammer connecting shaft2024-07-24 Hammer connecting shaft
00850065741055 - EquiLOX Lumbar Expandable Cage - Hammer power shaft2024-07-24 Hammer power shaft
00850065741062 - EquiLOX Lumbar Expandable Cage - Bone Graft Funnel2024-07-24 Bone Graft Funnel
00850065741079 - EquiLOX Lumbar Expandable Cage - Bone Impactor2024-07-24 Bone impactor

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