510(k) K231840

Device: CastleLoc-S Posterior Cervical Fixation System
Applicant: L&K BIOMED Co., Ltd.
510(k) number: K231840
Product code: NKG
Decision: Substantially Equivalent (SESE)
Decision date: 2023-07-20
Date received: 2023-06-22
Regulation: 888.3075
Classification name: Posterior Cervical Screw System
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Katherine Kim
Address: #101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil Giheung-Gu, Yongin-Si KR 17015 17015

FDA Registration Numbers

3007485169
3006128100
3006563559
2183449
9610612
3014763043
9615021
1835444
3013194153
9611813
2648623
3008110533
3006984710
3010047454
3009049161
3005562917
3005874553
3007993775
3012711663
3018094310
3009973505
3010863450
1833824
1043653
3008868758
2028632
3014725904
3006378738
3005823819
3009790163
3013491327
3008262872
3009144915
3010363503
1000432246
2031966
1824199
8043792
3010120148
3014680795
1526439
9611827
3004024955
3000170817
3003761012
3008812560
3008583793
3009882675
3006783837
3015869493
3005819474
1000461041
3017528621
3005180920
3005031160
3000270450
3009417901
3015440604
3014782362
3005677016
3004188066
2647346
3006493760
3015831087
2953359
3012120772
3009380063
9612420
1226544
3007728266
3016438694
3003661942
3008285983
1526534
3011187779
3019837678
3012994232
3010120104
3009504230
3004717358

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
08800061395273	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395266	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395259	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395242	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395235	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395228	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395211	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395204	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395198	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395181	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-07
08800061395105	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395129	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395150	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395143	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395136	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395112	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395075	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395099	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395082	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395174	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061395167	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-04
08800061394962	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061394979	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061394986	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061394993	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061395006	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061395037	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061395051	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061395044	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03
08800061395013	CastleLoc-S Posterior Cervical Fixation System	L&K BIOMED CO. ,LTD.	2023-08-03

Other 510(k) Records For Product Code NKG

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K250866	Sovereign Posterior Cervical System	Met One Technologies, LLC	2025-05-20
K242674	Freedom Posterior Cervical Screws	Signature Orthopaedics Pty, Ltd.	2025-05-13
K250332	Virage® OCT Spinal Fixation System	Highridge Medical, LLC	2025-04-04
K242516	EUROPA Posterior Cervical Fusion System	MiRus, LLC	2024-11-19
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K233332	Statera-C Spinal System	K&J Consulting Corp.	2023-11-27
K233078	Posterior Cervical Spine System	Double Medical Technology, Inc.	2023-11-22
K233366	SYMPHONY OCT System	Medos International SARL	2023-11-09
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