Phalangeal Fixation System

FDA 510(k) K994232 · Medcanica, Inc.

Substantially Equivalent

510(k) numberK994232

Submission

Device name
Phalangeal Fixation System
Applicant
Medcanica, Inc.
Miami, FL, US
Received
December 16, 1999
Decision date
March 1, 2000
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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More from OSSIO , Ltd.

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K011373Instrument Damping PortDRC · Traditional 10/12/2001SE
K011349Intercostal Lockable-Directable PortDRC · Traditional 10/05/2001SE
K991486Ultra-CbxDWZ · Traditional 11/05/1999SE
K991064Metacarpal Fixation SystemHTY · Traditional 06/23/1999SE

Questions and answers

When was Phalangeal Fixation System cleared by the FDA?

Phalangeal Fixation System (K994232) received a 510(k) decision of Substantially Equivalent on March 1, 2000, 76 days after the submission was received.

What is the product code of K994232?

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