TowerLOX EXT Cannulated Polyaxial EXT Screw 4.5 x 35mm

GUDID M7391613545350

TowerLOX EXT Cannulated Polyaxial EXT Screw 4.5 x 35mm

CAPTIVA SPINE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDM7391613545350
NIH Device Record Key6b73f9cb-48fd-466c-91bc-da0338f843cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTowerLOX EXT Cannulated Polyaxial EXT Screw 4.5 x 35mm
Version Model Number16135-4535
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

Customer Support Contacts

Phone561-277-9480
Emailinfo@captivaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7391613545350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7391613545350]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-09
Device Publish Date2020-04-01

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.