Cleared Special

K082146 - METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
(FDA 510(k) Clearance)

K082146 · Aesculap Implant Systems, Inc. · Orthopedic

Sep 2008

Decision

41d

Days

Class 2

Risk

K082146 is an FDA 510(k) clearance for the METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code LWJ), submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 9, 2008, 41 days after receiving the submission on July 30, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number	K082146 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2008
Decision Date	September 09, 2008
Days to Decision	41 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LWJ — Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3360