ExsoMed INnate NanoTM Lag Screw System

FDA 510(k) K220892 · Exsomed Corp.

Substantially Equivalent

510(k) numberK220892

Submission

Device name
ExsoMed INnate NanoTM Lag Screw System
Applicant
Exsomed Corp.
Aliso Viejo, CA, US
Received
March 28, 2022
Decision date
April 27, 2022
Decision
Substantially Equivalent (SESE)
Type
Special 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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K253108VEOFIX Snap Off ScrewHWC · Traditional Steps Ortho06/05/2026SE
K261154CoLink® & CoLag® Non-Sterile ScrewsHWC · Special In2Bones USA, LLC05/30/2026SE
K261241TriMed Compression ScrewsHWC · Special TriMed, Inc.05/14/2026SE
K254215Arthrex Beaming SystemHWC · Traditional Arthrex, Inc.05/08/2026SE

More from Arthrex, Inc.

510(k)DeviceDecision
K201430InFrame™ Cannulated Fixation SystemHWC · Special 06/20/2020SE
K192473Exsomed Wrist Plating SystemHRS · Traditional 12/03/2019SE
K183603INnate Cannulated Screw SystemHWC · Special 03/12/2019SE

Questions and answers

When was ExsoMed INnate NanoTM Lag Screw System cleared by the FDA?

ExsoMed INnate NanoTM Lag Screw System (K220892) received a 510(k) decision of Substantially Equivalent on April 27, 2022, 30 days after the submission was received.

What is the product code of K220892?

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