DeviceClearance

Product code KWQ— Orthopedic

Pyrenees Cervical Plate System

Classification name
Appliance, Fixation, Spinal Intervertebral Body
Device class
Class 2
Regulation
21 CFR 888.3060
Advisory panel
Orthopedic
Total cleared
667
First cleared
Most recent

Market context for product code KWQ

FDA has cleared 667 devices under product code KWQ between 1979 and 2026, filed by 280 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KWQ

Adverse events under product code KWQ

product code KWQ
Death
8
Injury
1,212
Malfunction
1,233
Total
2,453

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KWQ

1–100 of 667

Data sourced from openFDA. This site is unofficial and independent of the FDA.