FDA product code ISS: Prosthesis, Thigh Socket, External Component
ISS is the FDA product code for prosthesis, thigh socket, external component. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ISS. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Thigh Socket, External Component |
| Device class | Class I |
| Regulation | 21 CFR 890.3420 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every ISS clearance
Top ISS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthomedics | 1 | 1980-12-17 |
Most recent ISS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802911 | Orthomedics | A/K SOCKET | 1980-12-17 | 30 |
Recalls for ISS devices
openFDA lists no recalls for product code ISS.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system
Frequently asked questions
What is FDA product code ISS?
ISS is the FDA product code for prosthesis, thigh socket, external component. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is ISS?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ISS?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most ISS clearances?
Orthomedics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ISS
- Run a recall and safety report across every ISS manufacturer
- Watch product code ISS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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