REUNITE SCREWS

Screw, Fixation, Bone

BIOMET MANUFACTURING, INC.

The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Reunite Screws.

Pre-market Notification Details

• Device ID: K992301
• 510k Number: K992301
• Device Name: REUNITE SCREWS
• Classification: Screw, Fixation, Bone
• Applicant: BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Michelle L Mckinley
• Correspondent: Michelle L Mckinley; BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-08
• Decision Date: 1999-09-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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