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Asfora Anterior Cervical Plate System

FDA UDI

Class II (US FDA UDI)

by Medical Designs Llc

Identity

Trade Name
Asfora Anterior Cervical Plate System FDA UDI
Generic Name
Orthopaedic implant driver FDA UDI
Device Name
Screw Retention Driver FDA UDI
Model / Reference
11-1106-FD28 FDA UDI
Description
Screw Retention Driver FDA UDI

Identifiers

Primary DI / UDI-DI
M364111106FD280 FDA UDI
510(k) Number
K143688 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Orthopaedic implant driver FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant driver

Asfora Anterior Cervical Plate System by Medical Designs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant driver.

Cleared under the same submission

K143688 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Designs Llc

Sources (1)

  • FDA UDI d5b245e1-3ea1-4b2f-b7b8-64cb1c6e240c 34 fields · synced May 30, 2026