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

Prosthesis, Thigh Socket, External Component

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

ISS is the FDA product code for Prosthesis, Thigh Socket, External 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 no recalls.

Classification record

Product code
ISS
Device name
Prosthesis, Thigh Socket, External 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
0

Clearances, product code ISS

By decision year
1 clearance under product code ISS with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ISS by decision year
YearClearances
19801

Applicants with the most clearances

Product code ISS
Applicants holding the most 510(k) clearances under product code ISS
ApplicantClearances
Orthomedics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order