DyanBunion 7105-DSHR

GUDID 00850038154431

The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452.

CROSSROADS EXTREMITY SYSTEMS

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID00850038154431
NIH Device Record Key4b9cb7ac-9bc5-42f1-a4b8-81201a36b6fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDyanBunion
Version Model NumberDynaBunion Plate SHORT 15mm - RIGHT
Catalog Number7105-DSHR
Company DUNS058864308
Company NameCROSSROADS EXTREMITY SYSTEMS
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850038154431 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-11
Device Publish Date2023-08-03

On-Brand Devices [DyanBunion]

00850038154448The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D
00850038154431The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D
00850038154424The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D
00850038154417The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and D

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