PIN SCREW

Pin, Fixation, Threaded

BK MEDITECH CO., LTD.

The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Pin Screw.

Pre-market Notification Details

Device IDK061599
510k NumberK061599
Device Name:PIN SCREW
ClassificationPin, Fixation, Threaded
Applicant BK MEDITECH CO., LTD. 215-5 YODANG-LI, YANGGAM-MYUN Hwasung-si, Kyunggi-do,  KR
ContactByungjun Park
CorrespondentByungjun Park
BK MEDITECH CO., LTD. 215-5 YODANG-LI, YANGGAM-MYUN Hwasung-si, Kyunggi-do,  KR
Product CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-08
Decision Date2006-07-26
Summary:summary

NIH GUDID Devices

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