The JASPER Spinal Fixation System

GUDID 08800033847175

GBS Commonwealth Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08800033847175
NIH Device Record Keya24c3a9a-2f60-4f37-82c6-e91c3867119b
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe JASPER Spinal Fixation System
Version Model NumberL226-8540
Company DUNS694609156
Company NameGBS Commonwealth 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS108800033847175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800033847175]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-08
Device Publish Date2019-09-30

On-Brand Devices [The JASPER Spinal Fixation System]

08800033182436L188-5260
08800033182429L188-5255
08800033182412L188-5250
08800033182405L188-5245
08800033182399L188-5240
08800033182382L188-5235
08800033182375L188-5230
08800033182368L188-5225
08800033182351L188-5220
08800033182344L188-5215
08800033182337L188-5210
08800033182320L188-5160
08800033182313L188-5155
08800033182306L188-5150
08800033182290L188-5145
08800033182283L188-5140
08800033182276L188-5135
08800033182269L188-5130
08800033182252L188-5125
08800033182245L188-5120
08800033182238L188-5115
08800033182221L188-5110
08800033182214L187-5260
08800033182207L187-5255
08800033182191L187-5250
08800033182184L187-5245
08800033182177L187-5240
08800033182160L187-5235
08800033182153L187-5230
08800033182146L187-5225
08800033182139L187-5220
08800033182122L187-5215
08800033182115L187-5210
08800033182108L187-5160
08800033182092L187-5155
08800033182085L187-5150
08800033182078L187-5145
08800033182061L187-5140
08800033182054L187-5135
08800033182047L187-5130
08800033182030L187-5125
08800033182023L187-5120
08800033182016L187-5115
08800033182009L187-5110
08800033181996L186-5260
08800033181989L186-5255
08800033181972L186-5250
08800033181965L186-5245
08800033181958L186-5240
08800033181941L186-5235

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