DynaBridge DB-15-1515-B

GUDID 00819034023394

Superelastic Nitinol Implant Style B 15 x 15 x 15mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone staple, non-adjustable, non-sterile
Primary Device ID00819034023394
NIH Device Record Key7ed3d167-59b3-48f2-8c03-e0b55c454510
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaBridge
Version Model NumberDB-15-1515-B
Catalog NumberDB-15-1515-B
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
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 Datetrue
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
GS100819034023394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034023394]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-07
Device Publish Date2019-04-29

On-Brand Devices [DynaBridge]

00819034029273Sizer Wheel Kit
00819034028016Superelastic Nitinol Implant Style B 25mm x 20mm x 20mm
00819034028009Superelastic Nitinol Implant Style B 20mm x 20mm x 20mm
00819034027996Superelastic Nitinol Implant Style B 20mm x 15mm x 15mm
00819034027989Superelastic Nitinol Implant Style B 18mm x 18mm x 15mm
00819034027972Superelastic Nitinol Implant Style B 18mm x 18mm x 18mm
00819034027965Superelastic Nitinol Implant Style B 18mm x 15mm x 15mm
00819034027958Superelastic Nitinol Implant Style B 15mm x 15mm x 15mm
00819034027941Superelastic Nitinol Implant Style B 15mm x 12mm x 12mm
00819034027934Superelastic Nitinol Implant Style A 15mm x 12mm x 12mm
00819034027910Superelastic Nitinol Implant Style A 13mm x 10mm x 10mm
00819034027897Superelastic Nitinol Implant Style A 11mm x 10mm x 10mm
00819034027880Superelastic Nitinol Implant Style A 9 x 8 x 8mm (Single)
00819034027873Drill Guide Style B 25mm
00819034027866Drill Guide Style B 20mm
00819034027859Drill Guide Style B 18mm
00819034027842Drill Guide Style B 15mm
00819034027835Drill Guide Style A 15mm
00819034027828Drill Guide Style A 13mm
00819034027811Drill Guide Style A 11mm
00819034027804Sizer Wheel Style B
00819034027798Drill Guide Style A 9mm
00819034027781Sizer Wheel Style A
00819034027774Sizer Wheel Style B
00819034027255Sizer Wheel Style A
00819034025398Tamp Large
00819034025381Tamp Small
00819034025213Superelastic Nitinol Implant System Style B 15 x 12 x 12mm
00819034025206Superelastic Nitinol Implant Style B 15 x 12 x 12mm
00819034023776Tray Based Inserter 25mm
00819034023769Tray Based Inserter 20mm
00819034023752Tray Based Inserter 18mm
00819034023745Tray Based Inserter 15mm
00819034023738Tray Based Inserter 13mm
00819034023721Tray Based Inserter 11mm
00819034023714Tray Based Inserter 9mm
00819034023653Calibrated Drill 15mm Length 2.1mm
00819034023639Targeting Rod Large
00819034023622Targeting Rod Small
00819034023615Calibrated Drill 2.8mm
00819034023608Calibrated Drill 15mm Length 2.1mm
00819034023592Calibrated Drill 2.1mm
00819034023585Superelastic Nitinol Implant System Style B 25 x 20 x 20m
00819034023578Superelastic Nitinol Implant System Style B 20 x 20 x 20mm
00819034023561Superelastic Nitinol Implant System Style B 20 x 15 x 15mm
00819034023554Superelastic Nitinol Implant System Style B 18 x 18 x 15mm
00819034023547Superelastic Nitinol Implant System Style B 18 x 18 x 18mm
00819034023530Superelastic Nitinol Implant System Style B 18 x 15 x 15mm
00819034023523Superelastic Nitinol Implant System Style B 15 x 15 x 15mm
00819034023516Superelastic Nitinol Implant System Style A 15 x 12 x 12mm

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