Cleared Special

K202484 - Cordera Hip System
(FDA 510(k) Clearance)

K202484 · Conformis, Inc. · Orthopedic

Sep 2020

Decision

24d

Days

Class 2

Risk

K202484 is an FDA 510(k) clearance for the Cordera Hip System. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH).

Submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on September 24, 2020, 24 days after receiving the submission on August 31, 2020.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K202484 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2020
Decision Date	September 24, 2020
Days to Decision	24 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358