BK Meditech Co., Ltd.
Hwaseong-si Gyeonggi, KR
BK MEDITECH CO., LTD. appears in FDA device records in Hwaseong-si Gyeonggi, KR. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for BK Meditech Co., Ltd. between 2006 and 2020. The busiest year on record is 2014, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2018 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200981 | Mega Plus MIS Spine System | NKB | Substantially Equivalent | |
| K183080 | Mega Plus Spine System | NKB | Substantially Equivalent | |
| K173180 | Mega Plus Spine System | NKB | Substantially Equivalent | |
| K140577 | INNESIS PEEK TL CAGE | MAX | Substantially Equivalent | |
| K132483 | INNESIS PEEK CERVICAL CAGE | ODP | Substantially Equivalent | |
| K120464 | INNESIS PEEK CAGE | MAX | Substantially Equivalent | |
| K110426 | DYNA-EXTOR II | KTT | Substantially Equivalent | |
| K090424 | DVX SPINE SYSTEM | MNH | Substantially Equivalent | |
| K080876 | DVX SPINE SYSTEM | MNH | Substantially Equivalent | |
| K072436 | MEGA SPINE SYSTEM | MNI | Substantially Equivalent | |
| K061599 | PIN SCREW | JDW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004176895 | 3004176895 | BK MEDITECH CO., LTD. | 58, Eunhaengnamu-ro, Yanggam-myeon, Hwaseong-si Gyeonggi 18633 KR | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- GESBlade, Scalpel
- KTZCaliper
- HTFCurette
- FZTCutter, Surgical
- HXKHolder, Needle; Orthopedic
- HWAImpactor
- HWNInstrument, Compression
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- JDWPin, Fixation, Threaded
- HXBProbe
- HXOPusher, Socket
- HTRRasp
- GADRetractor
- HXXScrewdriver
- HWXTap, Bone
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain