ACE 3.5MM CORTICAL BONE SCREW

Screw, Fixation, Bone

ACE MEDICAL CO.

The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace 3.5mm Cortical Bone Screw.

Pre-market Notification Details

• Device ID: K905048
• 510k Number: K905048
• Device Name: ACE 3.5MM CORTICAL BONE SCREW
• Classification: Screw, Fixation, Bone
• Applicant: ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061
• Contact: Gloria Teske
• Correspondent: Gloria Teske; ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-08
• Decision Date: 1991-01-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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