Cleared Traditional

BHR BIPOLAR FEMORAL HEAD COMPONENT

K915528 · Implantology Corp. · Orthopedic
Jun 1993
Decision
567d
Days
Class 2
Risk

About This 510(k) Submission

K915528 is an FDA 510(k) clearance for the BHR BIPOLAR FEMORAL HEAD COMPONENT, a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II — Special Controls, product code LZY), submitted by Implantology Corp. (Pine Brook, US). The FDA issued a Cleared decision on June 29, 1993, 567 days after receiving the submission on December 10, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K915528 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1991
Decision Date June 29, 1993
Days to Decision 567 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360