# L&K BIOMED Co., Ltd.

- Location (FDA's records): Yongin-Si, KR
- FDA decisions: 58 (2010–2026): 58 510(k) clearances
- Product codes: NKB (17), MAX (11), KWQ (8), ODP (5), NKG (4), OUR (4), MNH (3), HRS (3), MNI (2), KWP (1)
- 510(k) review time since 2016: median 34 days, against 82 for FDA's reviews in the same codes and years (26 of 39 faster)
- Predicates its devices cite: 238 (120 its own); citations of its devices by later devices: 168 (120 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 Corp.: 12 (https://510kreport.com/company/stryker)
- Solco Biomedical Co., Ltd.: 9 (https://510kreport.com/company/solco-biomedical)
- GS Medical Co., Ltd.: 8 (https://510kreport.com/company/gs-medical)
- Spineart: 7 (https://510kreport.com/company/spineart)
- Aegis Spine, Inc.: 7 (https://510kreport.com/company/aegis-spine)
- Stryker Spine: 7 (https://510kreport.com/company/stryker-spine)
- Medtronic Sofamor Danek: 6 (https://510kreport.com/company/medtronic-sofamor-danek)
- U&I Corporation: 6 (https://510kreport.com/company/u-i)

## Firms that cite its devices most
- Accel Spine: 13 (https://510kreport.com/company/accel-spine)
- Aegis Spine, Inc.: 8 (https://510kreport.com/company/aegis-spine)
- Gbs Commonwealth Co., Ltd.: 6 (https://510kreport.com/company/gbs-commonwealth)
- Biomet Spine (Aka Ebi, LLC): 3 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Corentec Co., Ltd.: 3 (https://510kreport.com/company/corentec)
- Bm Korea Co., Ltd.: 2 (https://510kreport.com/company/bm-korea)
- Coligne AG: 2 (https://510kreport.com/company/coligne)
- Oak Tree Engineering, LLC: 2 (https://510kreport.com/company/oak-tree-engineering)

## Its most-cited devices
- K120270: Venus Spinal Fixation System (2012), cited by 9
- K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage (2011), cited by 7
- K143363: VENUS Spinal Fixation System (2015), cited by 7
- K171813: OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System (2017), cited by 7
- K182544: AccelFix Spinal Fixation System (2019), cited by 7
- K151140: LnK Lumbar Interbody Fusion Cage System (2015), cited by 6

## Recent decisions
- K262489: BluEX Cervical Expandable Cage System (Aug 18, 2026)
- K260840: BluEX Cervical Expandable Cage System (May 16, 2026)
- K261112: CastleLoc-P Anterior Cervical Plate System (May 6, 2026)
- K261130: AccelFix Spinal Fixation System (May 5, 2026)
- K260448: CastleLoc Pectus Bar System (Mar 19, 2026)
- K251940: PathLoc Lumbar Plate System (Mar 3, 2026)
- K251741: PathLoc Lumbar Interbody Fusion Cage System (Jul 8, 2025)
- K250892: CastleLoc Pectus Bar System (Apr 25, 2025)

Source page: https://510kreport.com/company/l-k-biomed