REGENERX RINGLOC + MODULAR ACETABULAR SHELLS

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 Regenerx Ringloc + Modular Acetabular Shells.

Pre-market Notification Details

• Device ID: K070369
• 510k Number: K070369
• Device Name: REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Robert Friddle
• Correspondent: Robert Friddle; BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: LPH
• Subsequent Product Code: JDG
• Subsequent Product Code: JDI
• Subsequent Product Code: KWZ
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: MAY
• Subsequent Product Code: MBL
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-08
• Decision Date: 2007-03-09
• Summary: summary

NIH GUDID Devices

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