# Bk Meditech, Co., Ltd.

- Location (FDA's records): Stillwater, MN
- FDA decisions: 11 (2006–2020): 11 510(k) clearances
- Product codes: NKB (3), MAX (2), MNH (2), KTT (1), ODP (1), MNI (1), JDW (1)
- 510(k) review time since 2016: median 119 days, against 61 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 34 (6 its own); citations of its devices by later devices: 11 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Spine: 4 (https://510kreport.com/company/stryker-spine)
- Renovis Surgical Technologies, LLC: 2 (https://510kreport.com/company/renovis-surgical-technologies)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Biomet Spine (Aka Ebi, LLC): 1 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Solco Biomedical Co., Ltd.: 1 (https://510kreport.com/company/solco-biomedical)

## Firms that cite its devices most
- Otis Biotech Co., Ltd.: 1 (https://510kreport.com/company/otis-biotech)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Seohancare Co., Ltd.: 1 (https://510kreport.com/company/seohancare)
- Medyssey USA, Inc.: 1 (https://510kreport.com/company/medyssey-usa)
- Lsk Biopartners, Inc.: 1 (https://510kreport.com/company/lsk-biopartners)

## Its most-cited devices
- K120464: Innesis Peek Cage (2013), cited by 3
- K072436: Mega Spine System (2007), cited by 3
- K183080: Mega Plus Spine System (2018), cited by 2
- K140577: Innesis Peek TL Cage (2014), cited by 1
- K173180: Mega Plus Spine System (2018), cited by 1
- K080876: DVX Spine System (2008), cited by 1

## Recent decisions
- K200981: Mega Plus MIS Spine System (Aug 11, 2020)
- K183080: Mega Plus Spine System (Dec 10, 2018)
- K173180: Mega Plus Spine System (Mar 15, 2018)
- K140577: Innesis Peek TL Cage (Oct 1, 2014)
- K132483: Innesis Peek Cervical Cage (Apr 2, 2014)
- K120464: Innesis Peek Cage (Jan 18, 2013)
- K110426: Dyna-Extor II (Nov 2, 2011)
- K090424: DVX Spine System (May 14, 2009)

Source page: https://510kreport.com/company/bk-meditech