← Back to catalogue

DynaBridge

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
DynaBridge FDA UDI
Generic Name
Surgical drill guide, single-use, non-sterile FDA UDI
Device Name
Drill Guide Style A 9mm FDA UDI
Model / Reference
CD-DB-4009-A FDA UDI
Description
Drill Guide Style A 9mm FDA UDI

Identifiers

Catalog Number
CD-DB-4009-A FDA UDI
Primary DI / UDI-DI
00819034027798 FDA UDI
510(k) Number
K181815 FDA UDI
FDA Product Code
JDR FDA UDI
GMDN Term
Surgical drill guide, single-use, 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, single-use, non-sterile

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

Similar devices

Also classified as Surgical drill guide, single-use, non-sterile.

Cleared under the same submission

K181815 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI 6197184b-1de0-4e12-be34-ace856c5e088 35 fields · synced May 30, 2026