JAZZ FRAME 350752

GUDID 03607503507523

JAZZ Frame – Straight Rod L 500 CoCr

IMPLANET

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID03607503507523
NIH Device Record Key03a46cf5-a537-4be0-9fd6-a7368ae325df
Commercial Distribution StatusIn Commercial Distribution
Brand NameJAZZ FRAME
Version Model NumberJAZZ Frame – Straight Rod L 500 CoCr
Catalog Number350752
Company DUNS291993439
Company NameIMPLANET
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length500 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103607503507523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-09-26
Device Publish Date2017-01-24

On-Brand Devices [JAZZ FRAME]

03607503507554JAZZ Frame – Straight Rod Dia. 6.0 L600
03607503507547JAZZ Frame – Straight Rod Dia. 6.0 L500
03607503507530JAZZ Frame – Straight Rod L 600 CoCr
03607503507523JAZZ Frame – Straight Rod L 500 CoCr
03607503507516JAZZ Frame – Straight Rod L 600
03607503507509JAZZ Frame – Straight Rod L 500
03607503507271JAZZ Frame - T-Bar Dia.4,5 L25
03607503507233JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L35
03607503507226JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L30
03607503507219JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L25
03607503507295JAZZ Frame - T-Bar Dia.4,5 L35
03607503507288JAZZ Frame - T-Bar Dia.4,5 L30

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