MiniBunion 280041

GUDID 00815432029228

The MiniBunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

CROSSROADS EXTREMITY SYSTEMS

Surgical drill guide obturator
Primary Device ID00815432029228
NIH Device Record Keyd8d74dab-8bc1-421f-a691-c85e956e6c41
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniBunion
Version Model NumberMiniBunion Saw Guide
Catalog Number280041
Company DUNS058864308
Company NameCROSSROADS EXTREMITY SYSTEMS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
GS100815432029228 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


[00815432029228]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-07
Device Publish Date2021-04-29

On-Brand Devices [MiniBunion]

00815432029228The MiniBunion Plating System is intended for fixation of osteotomies and corrective procedures
00810112597875MiniBunion Saw Guide
00810112597868MIS Bunion Plate Inserter
00810112597851MiniBunion Instruments Tray
00810112597844MiniBunion Non-Locking Drill Guide

Trademark Results [MiniBunion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MINIBUNION
MINIBUNION
88244621 not registered Live/Pending
Crossroads Extremity Systems
2018-12-28

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