DeviceClearance

Product code HWE— General, Plastic Surgery

HALL MODULAR ACETABULAR REAMER SYSTEM

Classification name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Total cleared
76
First cleared
Most recent

Market context for product code HWE

FDA has cleared 76 devices under product code HWE between 1976 and 2015, filed by 54 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 HWE

Adverse events under product code HWE

product code HWE
Death
4
Injury
448
Malfunction
19,856
Other
2
Total
20,310

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 HWE

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