Skip to content

Parker Quality & Compliance

PQC Reg Watch

Sponsor this week — one slot, $75, newsletter line and this bar

510(k) clearance

G7® Acetabular System

FDA 510(k) source

510(k) number
K261453
Applicant
Zimmer Biomet
Decision date
Sep 23, 2026
Date received
May 1, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
LPH
Device type
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class
Class II
Regulation
21 CFR 888.3358
Advisory committee
Orthopedic
Statement or summary
Summary
Third party
N
Location
Warsaw, IN, US