Cannulated Polyaxial Reduction Screw 4.5 x 50mm

GUDID M739243345500

Cannulated Polyaxial Reduction Screw 4.5 x 50mm

CAPTIVA SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM739243345500
NIH Device Record Keybabdceef-448f-48a1-a069-7a9024a3bfeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Polyaxial Reduction Screw 4.5 x 50mm
Version Model Number2433-4550
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
HIBCCM739243345500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M739243345500]

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

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