FDA product code LYP: Accessories, Fixation, Spinal Interlaminal

LYP is the FDA product code for accessories, fixation, spinal interlaminal. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under LYP. The average 510(k) review took 78 days (median 78).

Classification

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

Top LYP applicants

Most recent LYP clearances

Recalls for LYP devices

openFDA lists no recalls for product code LYP.

Frequently asked questions

What is FDA product code LYP?

LYP is the FDA product code for accessories, fixation, spinal interlaminal. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel.

What device class is LYP?

Class II, regulation 21 CFR 888.3050. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 78 days from receipt to decision (median 78).

Which companies have the most LYP clearances?

Orthopedic Systems, Inc. (1).

Next steps

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