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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 driver FDA UDI
Device Name
Calc Slide Inserter 14mm (Sterile) FDA UDI
Model / Reference
CD-DB-CI14-S FDA UDI
Description
Calc Slide Inserter 14mm (Sterile) FDA UDI

Identifiers

Catalog Number
CD-DB-CI14-S FDA UDI
Primary DI / UDI-DI
00840124513624 FDA UDI
510(k) Number
K181815 FDA UDI
FDA Product Code
JDR FDA UDI
GMDN Term
Orthopaedic bone staple driver 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 driver

DynaBridge is a hand-held surgical instrument designed to facilitate the insertion of bone staples into fractured bones. This innovative device features a high-grade stainless steel or titanium alloy construction, allowing for precise and controlled force delivery. The orthopaedic bone staple driver provides a reliable and effective solution for various medical applications.

Similar devices

Also classified as Orthopaedic bone staple driver.

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 05f0152b-bad8-4673-aec4-4c9049954cfb 35 fields · synced Jun 24, 2026