LOSPA IS Spinal Instrument

GUDID 08800017278506

ANTI TORQUE WRENCH

Corentec Co., Ltd

External spinal fixation system
Primary Device ID08800017278506
NIH Device Record Key4ebd60e3-3065-4f38-a327-243751835293
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA IS Spinal Instrument
Version Model NumberSI.AP6.0032
Company DUNS688739895
Company NameCorentec Co., Ltd
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 Datetrue
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
GS108800017278506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800017278506]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-17
Device Publish Date2020-04-09

Devices Manufactured by Corentec Co., Ltd

08800017299006 - Lospa Surgical Instruments2024-11-08 Distal Cutting Guide S Phase2
08800068959591 - Lospa Surgical Instruments2024-11-08 EM Assembly Rod
08800068959607 - Lospa Surgical Instruments2024-11-08 EM Alignment Assembly Rod
08800068959973 - Lospa Surgical Instruments2024-11-08 Chamfer Cutting Guide #03
08800068959980 - Lospa Surgical Instruments2024-11-08 Chamfer Cutting Guide #04
08800068959997 - Lospa Surgical Instruments2024-11-08 Chamfer Cutting Guide #05
08800068960009 - Lospa Surgical Instruments2024-11-08 Chamfer Cutting Guide #07
08800068960016 - Lospa Surgical Instruments2024-11-08 Chamfer Cutting Guide #09

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