Echo Bi-Metric Microplasty Hip System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Echo Bi-metric Microplasty Hip System.

Pre-market Notification Details

• Device ID: K143009
• 510k Number: K143009
• Device Name: Echo Bi-Metric Microplasty Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587
• Contact: Julie Gantenberg, M.s.,rac
• Correspondent: Julie Gantenberg, M.s.,rac; BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: OQG
• Subsequent Product Code: OQH
• Subsequent Product Code: OQI
• Subsequent Product Code: PBI
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-20
• Decision Date: 2014-12-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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