FDA.reportPublic FDA data

DynaBridge

Primary DI
00840124519121
Brand
DynaBridge
Company
FUSION ORTHOPEDICS, LLC
Model
TN-DB-2050
Catalog number
TN-DB-2050
Device description
Small Tamp
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124519121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124519121008401245191218401245191210840124519121

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124525474PolyLock MidfootMF-LK-2748MF-LK-27482026-03-10
00840124525481PolyLock MidfootMF-NL-2748MF-NL-27482026-03-10
00840124525450Depth GaugeTN-DG-8000TN-DG-80002026-03-06
00840124525375FuzeFix Max FTFX-FT-2532-SFX-FT-2532-S2026-02-17
00840124525382FuzeFix Max FTFX-FT-2534-SFX-FT-2534-S2026-02-17
00840124525399FuzeFix Max FTFX-FT-2536-SFX-FT-2536-S2026-02-17
00840124525405FuzeFix Max FTFX-FT-2538-SFX-FT-2538-S2026-02-17
00840124525412FuzeFix Max FTFX-FT-2542-SFX-FT-2542-S2026-02-17
00840124525429FuzeFix Max FTFX-FT-2544-SFX-FT-2544-S2026-02-17
00840124525436FuzeFix Max FTFX-FT-2546-SFX-FT-2546-S2026-02-17
00840124525443FuzeFix Max FTFX-FT-2548-SFX-FT-2548-S2026-02-17
00840124525320FuzeFix MiniTN-FX-6012TN-FX-60122026-02-03
00840124525337FuzeFix MiniTN-FX-6013TN-FX-60132026-02-03
00840124525344Metalogix RevolutionTN-TR-0095TN-TR-00952026-02-03
00840124525351Metalogix RevolutionTN-TR-0094TN-TR-00942026-02-03
00840124525368Metalogix RevolutionTN-TR-0090TN-TR-00902026-02-03
00840124525245FuzeFix MiniTN-FX-6011TN-FX-60112026-01-22
00840124525252Metalogix RevolutionTN-TR-0091TN-TR-00912026-01-22
00840124525269Metalogix RevolutionMX-RP-0120MX-RP-01202026-01-22
00840124525276Metalogix RevolutionMX-RP-0140MX-RP-01402026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060267134523Fastlok 8mm x 23mmXIROS LTDJDR2026-02-16
05060267134530Fastlok 6mm x 23mmXIROS LTDJDR2026-02-16
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10193489020946MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
00810111225236Lapiplasty SpeedPlate - TMTTreace Medical Concepts, Inc.JDR2026-01-23
00810135964180VertexNVISION BIOMEDICAL TECHNOLOGIES, INC.JDR2025-12-17
00810111224918TMC FastPitch ScrewsTreace Medical Concepts, Inc.JDR2025-12-12
00810111225175TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225199TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225373TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111224857TMC SpeedMTPTreace Medical Concepts, Inc.JDR2025-11-14
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