FDA Registration Active 🇰🇷 South Korea

LnK MIS Spinal System / PathLoc-L MIS Spinal System / AccelFix-MIS Spinal System

Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
Products
1
Proprietary Names
1665
Establishment Types
1
Classifications
1

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
K200789

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
Thoracolumbosacral Pedicle Screw System NKB

Proprietary Names

LnK MIS Spinal System / PathLoc-L MIS Spinal System / AccelFix-MIS Spinal System 2307-6555S 2530-55240S 2600-5535S 2300-6540S 2511-5570 2306-5555S 2531-55150 2540-60130 2541-60150S 2600-7560S 2300-75135S 2530-6045S 2300-5590S 2511-60550 2310-5545S 2302-6065S 2311-5555S 2300-55120S 2300-60145S 2407-7560S 2405-7540S 2530-6080 2302-5550S 2530-6060S 2600-7550S 2411-6560S 2300-95145S 2511-5595S 2512-60130S 2531-5565S 2512-6075S 2530-55130 2302-7075S 2302-8070S 2404-5555S 2302-8040S 2620-7560S 2620-5560S 2620-7530 2531-60100 2511-60240S 2307-6535S 2300-55100S 2300-60105S 2512-5550 2530-60140 2300-9075S 2310-6560S 2530-60230 2530-55210S 2405-7560S 2531-6045S 2308-6545S 2530-60150 2300-7085S 2531-55450 2530-5570S 2620-6545S 2302-60125S 2511-60400 2300-5555S 2531-55110 2300-55150S 2300-9055S 2300-8595S 2800-5560S 2408-6545S 2302-9565S 2302-90150S 2300-7545S 2541-6040S 2530-60200 2302-7030S 2300-6575S 2302-9545S 2531-55250 2304-7560S 2412-6535S 2541-55130S 2511-55290S 2304-5535S 2300-65120S 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Establishment Types

Manufacture Medical Device