Orthocor Knee System Basic

FDA 510(k) K091996 · Orthocor Medical

Substantially Equivalent

510(k) numberK091996

Submission

Device name
Orthocor Knee System Basic
Applicant
Orthocor Medical
Mccordsville, IN, US
Received
July 2, 2009
Decision date
December 15, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5290
Specialty
Physical Medicine

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Questions and answers

When was Orthocor Knee System Basic cleared by the FDA?

Orthocor Knee System Basic (K091996) received a 510(k) decision of Substantially Equivalent on December 15, 2009, 166 days after the submission was received.

What is the product code of K091996?

The FDA product code is ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.