EXTERNAL ARTICULATION

Component, Traction, Invasive

ACE ORTHOPEDIC MANUFACTURING CO.

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

Pre-market Notification Details

• Device ID: K781840
• 510k Number: K781840
• Device Name: EXTERNAL ARTICULATION
• Classification: Component, Traction, Invasive
• Applicant: ACE ORTHOPEDIC MANUFACTURING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JEC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-10-27
• Decision Date: 1978-11-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868071386	K781840	000
00887868070518	K781840	000
00887868070372	K781840	000