Field Orthopaedics Micro Screw System

FDA 510(k) K180348 · Field Orthopaedics Pty, Ltd.

Substantially Equivalent

510(k) numberK180348

Submission

Device name
Field Orthopaedics Micro Screw System
Applicant
Field Orthopaedics Pty, Ltd.
Brisbane, AU
Received
February 8, 2018
Decision date
July 17, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HWC – Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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K261154CoLink® & CoLag® Non-Sterile ScrewsHWC · Special In2Bones USA, LLC05/30/2026SE
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Questions and answers

When was Field Orthopaedics Micro Screw System cleared by the FDA?

Field Orthopaedics Micro Screw System (K180348) received a 510(k) decision of Substantially Equivalent on July 17, 2018, 159 days after the submission was received.

What is the product code of K180348?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.