FDA product code HSR: Unit, Traction, Hip, Non-Powered, Non-Penetrating

HSR is the FDA product code for unit, traction, hip, non-powered, non-penetrating. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under HSR. The average 510(k) review took 8 days (median 8).

Classification

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Recalls for HSR devices

openFDA lists no recalls for product code HSR.

Frequently asked questions

What is FDA product code HSR?

HSR is the FDA product code for unit, traction, hip, non-powered, non-penetrating. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Orthopedic panel.

What device class is HSR?

Class I, regulation 21 CFR 888.5890. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code HSR?

Across 1 cleared submissions the average was 8 days from receipt to decision (median 8).

Which companies have the most HSR clearances?

Orthopedic Equipment Co., Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code HSR
• Run a recall and safety report across every HSR manufacturer
• Watch product code HSR 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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