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DynaBridge

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
DynaBridge FDA UDI
Generic Name
Orthopaedic bone staple, non-adjustable, non-sterile FDA UDI
Device Name
Superelastic Nitinol Implant Style A 9 x 8 x 8mm (Single) FDA UDI
Model / Reference
DB-09-0808-SA1 FDA UDI
Description
Superelastic Nitinol Implant Style A 9 x 8 x 8mm (Single) FDA UDI

Identifiers

Catalog Number
DB-09-0808-SA1 FDA UDI
Primary DI / UDI-DI
00819034027880 FDA UDI
510(k) Number
K181815 FDA UDI
FDA Product Code
JDR FDA UDI
GMDN Term
Orthopaedic bone staple, non-adjustable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic bone staple, non-adjustable, non-sterile

DynaBridge by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple, non-adjustable, non-sterile.

Cleared under the same submission

K181815 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI d6e8a7e8-cec1-47fe-bf6f-a1a0f235c63f 35 fields · synced May 31, 2026