Hammerdesis™ Interphalangeal Fusion System

FDA 510(k) K231147 · Intelivation

Substantially Equivalent

510(k) numberK231147

Submission

Device name
Hammerdesis™ Interphalangeal Fusion System
Applicant
Intelivation
Plymouth Meeting, PA, US
Received
April 21, 2023
Decision date
September 14, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HTY – Pin, Fixation, Smooth
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Hammerdesis™ Interphalangeal Fusion System cleared by the FDA?

Hammerdesis™ Interphalangeal Fusion System (K231147) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 146 days after the submission was received.

What is the product code of K231147?

The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.