ACE HUMERAL NAIL

Rod, Fixation, Intramedullary And Accessories

ACE ORTHOPEDIC MANUFACTURING CO.

The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Ace Humeral Nail.

Pre-market Notification Details

• Device ID: K934643
• 510k Number: K934643
• Device Name: ACE HUMERAL NAIL
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: ACE ORTHOPEDIC MANUFACTURING CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; ACE ORTHOPEDIC MANUFACTURING CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-09-29
• Decision Date: 1994-03-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868031441	K934643	000
00887868031601	K934643	000
00887868031618	K934643	000
00887868031625	K934643	000
00887868031632	K934643	000
00887868031649	K934643	000
00887868031656	K934643	000
00887868032066	K934643	000
00887868032073	K934643	000
00887868032080	K934643	000
00887868032097	K934643	000
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00887868032110	K934643	000
00887868032127	K934643	000
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00887868031588	K934643	000
00887868031458	K934643	000
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00887868031502	K934643	000
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00887868031533	K934643	000
00887868031540	K934643	000
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00887868031564	K934643	000
00887868031571	K934643	000
00887868032134	K934643	000
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00887868004988	K934643	000
00887868004995	K934643	000
00887868005008	K934643	000
00887868005015	K934643	000
00887868005022	K934643	000
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00887868005046	K934643	000
00887868004919	K934643	000
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00887868005053	K934643	000