FDA Registration Active 🇰🇷 South Korea

CastleLoc-S Posterior Cervical Fixation System

Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
Products
2
Proprietary Names
1715
Establishment Types
1
Classifications
2

Registration Details

Registration Name
L&K BIOMED CO.,LTD.
Registration Number
3008285983
FEI Number
3008285983
Status
Active
Expiry Year
2025
Initial Importer
No
Address
#101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu
City
Yongin-SI Gyeonggi
Country
KR

Regulatory Submissions

510(k) Number
K200793

Owner / Operator

Firm Name
L&K BIOMED CO., LTD.
Operator Number
10033804
Address
#101, 201, 202, 16-25, Dongbaekjungang-ro,, 16 beon-gil, Giheung-gu
City
Youngin-si
State
Gyeonggi
Postal Code
17015
Country
KR
Correspondent
Kihyang Kim

US Agent

Business Name
ComplianceAcuity, Inc
Contact Name
Kevin Randall
Address
485 Clinton St, #888
City
Ridgeway
State
CO
ZIP
81432
Country
US
Phone
303 8280844

Products

Device Name Product Code
Posterior Cervical Screw System NKG
Appliance, Fixation, Spinal Interlaminal KWP

Proprietary Names

CastleLoc-S Posterior Cervical Fixation System LnK Posterior Cervical Fixation System 6114-5042 6116-5040 6125-62015S 6114-4532S 6111-4536S 6112-4538 6112-5016S 6125-41020S 6113-4546S 6135-3560S 6114-5030S 6126-61530S 6115-5012S 6113-3512S 6114-4538S 6112-3516S 6111-5536S 6116-5534S 6118-5550 6119-5548S 6114-5540S 6115-5030S 6111-4526 6116-5020 6115-3516S 6115-5550S 6121-3503S 6117-4548S 6113-5020 6113-3522S 6117-3542S 6121-3518S 6114-4522S 6126-52015S 6116-5516 6115-5040S 6119-3540S 6113-4544 6116-5036 6116-4522 6142-1068S 6116-5038S 6115-5514S 6119-5524S 6118-4550S 6144-0019S 6112-5028S 6113-5532S 6117-5046 6112-5546 6114-4530 6117-4530 6125-41540S 6111-5546S 6117-4022S 6116-5518S 6116-5544S 6115-5536S 6113-5024S 6121-3513S 6113-5544S 6115-4536 6121-3502S 6113-5014S 6142-3258S 6116-4520S 6111-4048S 6111-5012S 6119-5526 6115-5540 6119-4520 6116-4510 6115-3520S 6119-4030S 6113-5030S 6116-5524S 6114-5544S 6142-2140S 6116-5030S 6116-5510 6115-5028S 6119-5020 6111-5028S 6126-41525S 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Establishment Types

Manufacture Medical Device