REPROCESSED EXTERNAL FIXATION DEVICE

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

STERILMED, INC.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed External Fixation Device.

Pre-market Notification Details

• Device ID: K081586
• 510k Number: K081586
• Device Name: REPROCESSED EXTERNAL FIXATION DEVICE
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: STERILMED, INC. 11140 73RD AVE. NORTH Minneapolis, MN 55369
• Contact: Joshua Clarin
• Correspondent: Joshua Clarin; STERILMED, INC. 11140 73RD AVE. NORTH Minneapolis, MN 55369
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-06-05
• Decision Date: 2008-08-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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