REPROCESSED EXTERNAL FIXATION DEVICE

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

STERILEMED INC.

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

Pre-market Notification Details

• Device ID: K051957
• 510k Number: K051957
• Device Name: REPROCESSED EXTERNAL FIXATION DEVICE
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: STERILEMED INC. 11400 73RD AVE. N. Menneapolis, MN 55369
• Contact: Thomas A Dold
• Correspondent: Thomas A Dold; STERILEMED INC. 11400 73RD AVE. N. Menneapolis, 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: 2005-07-15
• Decision Date: 2005-09-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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