PHQ — Anterior Staple As Supplemental Fixation For Fusion Class II

FDA Device Classification

FDA product code PHQ covers "Anterior Staple As Supplemental Fixation For Fusion", a Class II medical device regulated under 21 CFR 888.3060. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
PHQ
Device Class
Class II
Regulation Number
888.3060
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

Anterior cervical device for supplemental fixation to support a fusion.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K200301pressioUNiTi ACDF Implant SystemFebruary 3, 2021
K133906medicrea internationalC-JAWS CERVICAL COMPRESSIVE STAPLEJuly 24, 2014