510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ISYClass I

Joint, Knee, External Limb Component

21 CFR 890.3420 / Physical Medicine
FDA source (opens on fda.gov)

ISY is the FDA product code for Joint, Knee, External Limb Component, a class I device type, regulated under 21 CFR 890.3420. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 17 recalls.

Classification record

Product code
ISY
Device name
Joint, Knee, External Limb Component
Regulation
21 CFR 890.3420
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
17

Clearances, product code ISY

By decision year
1 clearance under product code ISY with a decision year between 2010 and 2010, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ISY by decision year
YearClearances
20101

Applicants with the most clearances

Product code ISY
Applicants holding the most 510(k) clearances under product code ISY
ApplicantClearances
Rizzoli Ortopedica S.p.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order