MALLORY/HEAD - PF ACETABULAR COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mallory/head - Pf Acetabular Component.

Pre-market Notification Details

• Device ID: K861114
• 510k Number: K861114
• Device Name: MALLORY/HEAD - PF ACETABULAR COMPONENT
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Judith Dermody
• Correspondent: Judith Dermody; BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-03-25
• Decision Date: 1986-04-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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