KAPP SPINAL BUTTON

Washer, Bolt Nut

KAPP SURGICAL INSTRUMENT, INC.

The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Kapp Spinal Button.

Pre-market Notification Details

Device IDK843368
510k NumberK843368
Device Name:KAPP SPINAL BUTTON
ClassificationWasher, Bolt Nut
Applicant KAPP SURGICAL INSTRUMENT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-28
Decision Date1984-09-12

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