FDA product code NDL: Pin, Fixation, Smooth, Metallic

NDL is the FDA product code for pin, fixation, smooth, metallic. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under NDL, from 2 different applicants. The average 510(k) review took 96 days (median 96). FDA has posted 1 recall for NDL devices.

Classification

Compare with all 510(k) review times · Search every NDL clearance

Top NDL applicants

Most recent NDL clearances

Recalls for NDL devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-10-02.

Frequently asked questions

What is FDA product code NDL?

NDL is the FDA product code for pin, fixation, smooth, metallic. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.

What device class is NDL?

Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).

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

Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).

Which companies have the most NDL clearances?

Avanta Orthopaedics, Inc. (1); Tri-Med, Inc. (1).

Have NDL devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2019-10-02.

Next steps

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