SIRIUS FEMORAL STEM

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 Sirius Femoral Stem.

Pre-market Notification Details

• Device ID: K130610
• 510k Number: K130610
• Device Name: SIRIUS FEMORAL STEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Becky Earl
• Correspondent: Becky Earl; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JDI
• Subsequent Product Code: JDG
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: LZY
• Subsequent Product Code: MEH
• Subsequent Product Code: OQG
• Subsequent Product Code: OQH
• Subsequent Product Code: OQI
• Subsequent Product Code: PBI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-07
• Decision Date: 2013-08-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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