Lapidus Screw Kit

FDA 510(k) K262075 · Relja Innovations, LLC

Substantially Equivalent

510(k) numberK262075

Submission

Device name
Lapidus Screw Kit
Applicant
Relja Innovations, LLC
Wauwatosa, WI, US
Received
June 22, 2026
Decision date
July 22, 2026
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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Questions and answers

When was Lapidus Screw Kit cleared by the FDA?

Lapidus Screw Kit (K262075) received a 510(k) decision of Substantially Equivalent on July 22, 2026, 30 days after the submission was received.

What is the product code of K262075?

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