Cleared Traditional

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED

K934729 · Implantology Corp. · Orthopedic

Jul 1994

Decision

296d

Days

Class 2

Risk

About This 510(k) Submission

K934729 is an FDA 510(k) clearance for the UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Implantology Corp. (Pine Brook, US). The FDA issued a Cleared decision on July 22, 1994, 296 days after receiving the submission on September 29, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K934729 FDA.gov
FDA Decision	Cleared SN
Date Received	September 29, 1993
Decision Date	July 22, 1994
Days to Decision	296 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353