DARCO HEADLESS COMPRESSION SCREW

Screw, Fixation, Bone

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Darco Headless Compression Screw.

Pre-market Notification Details

• Device ID: K080850
• 510k Number: K080850
• Device Name: DARCO HEADLESS COMPRESSION SCREW
• Classification: Screw, Fixation, Bone
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Theresa Leister
• Correspondent: Theresa Leister; WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-26
• Decision Date: 2008-04-10
• Summary: summary

NIH GUDID Devices

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