SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM

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 Salvage/onocology Hip And Total Femur System.

Pre-market Notification Details

• Device ID: K974558
• 510k Number: K974558
• Device Name: SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; 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: 1997-12-05
• Decision Date: 1998-03-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868264771	K974558	000
00887868251702	K974558	000
00887868251719	K974558	000
00887868251726	K974558	000
00887868251733	K974558	000
00887868251740	K974558	000
00887868251757	K974558	000
00887868251764	K974558	000
00887868308215	K974558	000
00887868308376	K974558	000
00880304001534	K974558	000
00880304005402	K974558	000
00880304005426	K974558	000
00887868251696	K974558	000
00887868251689	K974558	000
00887868251672	K974558	000
00887868264948	K974558	000
00887868308857	K974558	000
00887868308864	K974558	000
00887868308871	K974558	000
00887868308888	K974558	000
00887868308895	K974558	000
00887868308901	K974558	000
00887868308918	K974558	000
00887868308925	K974558	000
00887868251641	K974558	000
00887868251658	K974558	000
00887868251665	K974558	000
00880304005518	K974558	000
00880304005778	K974558	000
00880304256330	K974558	000
00880304256408	K974558	000
00880304268753	K974558	000
00880304268777	K974558	000
00880304268784	K974558	000
00880304268791	K974558	000
00880304268807	K974558	000
00880304268821	K974558	000
00880304268838	K974558	000
00880304268845	K974558	000
00880304268852	K974558	000
00880304268869	K974558	000
00880304256323	K974558	000
00880304256316	K974558	000
00880304256293	K974558	000
00880304005938	K974558	000
00880304005983	K974558	000
00880304006393	K974558	000
00880304006423	K974558	000
00880304244498	K974558	000
00880304244504	K974558	000
00880304244511	K974558	000
00880304244528	K974558	000
00880304256231	K974558	000
00880304256255	K974558	000
00880304256262	K974558	000
00880304256286	K974558	000
00880304268876	K974558	000