ACE EXTERNAL BONE CLAMP PART #S11

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 Ace External Bone Clamp Part #s11.

Pre-market Notification Details

Device IDK791466
510k NumberK791466
Device Name:ACE EXTERNAL BONE CLAMP PART #S11
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 Received1979-08-01
Decision Date1979-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868070310 K791466 000

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