LACTOSORB PANELS AND FASTENERS

Plate, Fixation, Bone

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Panels And Fasteners.

Pre-market Notification Details

• Device ID: K984390
• 510k Number: K984390
• Device Name: LACTOSORB PANELS AND FASTENERS
• Classification: Plate, Fixation, Bone
• Applicant: BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Contact: Tracy J Bickel
• Correspondent: Tracy J Bickel; BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Product Code: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: MAI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-12-08
• Decision Date: 2000-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304424562	K984390	000
00880304418820	K984390	000
00880304418837	K984390	000
00880304418844	K984390	000
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