DeviceClearance

Product code LXH— Orthopedic

6.5MM HEX HANDLE

Classification name
Orthopedic Manual Surgical Instrument
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
Total cleared
58
First cleared
Most recent

Market context for product code LXH

FDA has cleared 58 devices under product code LXH between 1980 and 2019, filed by 36 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code LXH

Adverse events under product code LXH

product code LXH
Death
11
Injury
2,218
Malfunction
31,318
Total
33,547

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 LXH

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