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 IDK781840
510k NumberK781840
Device Name:EXTERNAL ARTICULATION
ClassificationComponent, Traction, Invasive
Applicant ACE ORTHOPEDIC MANUFACTURING CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-27
Decision Date1978-11-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868071386 K781840 000
00887868070518 K781840 000
00887868070372 K781840 000

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