Product code HWK— Orthopedic

PRECISION HARVEST & INLAY INSTRUMENT SET

Classification name
Trephine
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

Market context for product code HWK

FDA has cleared 1 device under product code HWK, all in 1985, filed by 1 applicant company. 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.

Top applicants under product code HWK

Recent clearances under product code HWK

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