OOG

Knee Arthroplasty Implantation System

Product code: OOG
Device name: Knee Arthroplasty Implantation System
Device class: Class 2
21 CFR: 21 CFR 888.3560
Medical specialty: Orthopedic
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 2

FDA classification definition

Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-20.

Number	Decision date	Applicant	Device name	Summary
K230850	2023-12-20	Enhatch, Inc.	United Orthopedic Knee Patient Specific Instrumentat	PDF

1 summaries are archived here for direct download.

Official FDA classification page: OOG

Classification and pathway per current FDA publications. Data from openFDA (CC0).