PERTROCHANTERIC FIXATOR 10050

GUDID 18032568030600

ANGULATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR

ORTHOFIX SRL

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable
Primary Device ID18032568030600
NIH Device Record Key106ce566-e3b8-407e-a5a2-00f56a142ed0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERTROCHANTERIC FIXATOR
Version Model Number1
Catalog Number10050
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exempttrue
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

Customer Support Contacts

Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568030600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568030600]

Moist Heat or Steam Sterilization


[18032568030600]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-17
Device Publish Date2018-04-06

On-Brand Devices [PERTROCHANTERIC FIXATOR]

18032568032383TROCAR D 6 MM LENGTH 240 MM
18032568032376TROCAR D 4.8 MM LENGTH 240 MM
18032568032369SPECIAL SCREW GUIDE 150 MM FOR PERTROCHANTERIC FIXATOR
18032568030631ROTATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR
18032568030617DISTAL ROTATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR
18032568030600ANGULATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR
18032568030587PERTROCHANTERIC FIXATOR WITH ALLEN WRENCH 5 MM
18053504366263Component. Not for sale. Used for reporting Direct Marking of assembly.

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