ORTHOPEDIC SALVAGE SYSTEM- OSS

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Orthopedic Salvage System- Oss.

Pre-market Notification Details

• Device ID: K052685
• 510k Number: K052685
• Device Name: ORTHOPEDIC SALVAGE SYSTEM- OSS
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Allison Koskey
• Correspondent: Allison Koskey; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-09-28
• Decision Date: 2005-10-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304475755	K052685	000
00880304462144	K052685	000
00880304240100	K052685	000
00880304037281	K052685	000