STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Stageone Disposable Cement Spacer Mold For Temporary Hip Prosthesis With Reinforcement Stem.

Pre-market Notification Details

• Device ID: K052990
• 510k Number: K052990
• Device Name: STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Lester F Padilla
• Correspondent: Lester F Padilla; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWY
• CFR Regulation Number: 888.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-24
• Decision Date: 2005-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304447172	K052990	000
00880304447165	K052990	000
00880304447158	K052990	000
00880304447141	K052990	000