DynaBunion 7108-DSTR

GUDID 00850038154486

DynaBunion Plate STD 18mm Right

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00850038154486
NIH Device Record Key3f756fcc-d8a1-4423-ae89-f75972645cda
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaBunion
Version Model NumberDynaBunion Plate STD 18mm Right
Catalog Number7108-DSTR
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
GS100850038154486 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-09
Device Publish Date2024-05-01

On-Brand Devices [DynaBunion ]

008500381542261500-48FH
00850038154189The MotoBAND™ CP DynaForce® MPJ Implant System is a bone plating system indicated for stabili
00850038154646DynaBunion IMA Reducer - Disposable Sterile
00850038154486DynaBunion Plate STD 18mm Right
00850038154462DynaBunion Plate STD 18mm - Left Sterile

Trademark Results [DynaBunion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DYNABUNION
DYNABUNION
88862985 not registered Live/Pending
Crossroads Extremity Systems
2020-04-07

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