FDA product code NDG: Washer, Bolt, Nut, Non-Spinal, Metallic

NDG is the FDA product code for washer, bolt, nut, non-spinal, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under NDG. The average 510(k) review took 56 days (median 56). FDA has posted 1 recall for NDG devices.

Classification

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

Top NDG applicants

Most recent NDG clearances

Recalls for NDG devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-28.

Frequently asked questions

What is FDA product code NDG?

NDG is the FDA product code for washer, bolt, nut, non-spinal, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.

What device class is NDG?

Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 56 days from receipt to decision (median 56).

Which companies have the most NDG clearances?

Synthes (Usa) (1).

Have NDG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2013-08-28.

Next steps

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