Cleared Traditional

MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING

K971206 · Howmedica Corp. · Orthopedic

Feb 1998

Decision

336d

Days

Class 2

Risk

About This 510(k) Submission

K971206 is an FDA 510(k) clearance for the MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 11, 1998, 336 days after receiving the submission on March 12, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K971206 FDA.gov
FDA Decision	Cleared SN
Date Received	March 12, 1997
Decision Date	February 11, 1998
Days to Decision	336 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

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