DeviceClearance

Product code PHQ— Orthopedic

C-JAWS CERVICAL COMPRESSIVE STAPLE

Classification name
Anterior Staple As Supplemental Fixation For Fusion
Device class
Class 2
Regulation
21 CFR 888.3060
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

FDA classification definition

“Anterior cervical device for supplemental fixation to support a fusion.”

— U.S. Food and Drug Administration, device classification record for product code PHQ under 21 CFR 888.3060, via openFDA

Market context for product code PHQ

FDA has cleared 2 devices under product code PHQ between 2014 and 2021, filed by 2 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

Top applicants under product code PHQ

Recent clearances under product code PHQ

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