# Medyssey USA, Inc.

- Location (FDA's records): Elk Grove Village, IL
- FDA decisions: 19 (2013–2023): 19 510(k) clearances
- Product codes: NKB (7), MAX (7), KWQ (3), NKG (1), ODP (1)
- 510(k) review time since 2016: median 86 days, against 95 for FDA's reviews in the same codes and years (8 of 15 faster)
- Predicates its devices cite: 49 (12 its own); citations of its devices by later devices: 16 (12 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
- Medyssey Co, Ltd.: 16 (https://510kreport.com/company/medyssey)
- Vertebron, Inc.: 2 (https://510kreport.com/company/vertebron)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- 4-Web, Inc.: 1 (https://510kreport.com/company/4-web)

## Firms that cite its devices most
- CG Bio Co., Ltd.: 1 (https://510kreport.com/company/cg-bio)
- Captiva Spine, Inc.: 1 (https://510kreport.com/company/captiva-spine)
- Seohancare Co., Ltd.: 1 (https://510kreport.com/company/seohancare)
- Signus Medizintechnik GmbH: 1 (https://510kreport.com/company/signus-medizintechnik)

## Its most-cited devices
- K170341: Medussa-PL Cage (2017), cited by 3
- K131878: Lliad, Kora, Zenius Pedicle Screw System (2013), cited by 3
- K140564: BN Lumbar Cage System (2014), cited by 2
- K171526: Zenius™, lliad™ and Kora™ Spinal Fixation Systems (2017), cited by 2
- K142835: Iliad Pedicle Screw System and Zenius Pedicle Screw System (2015), cited by 2
- K183409: Athena II Cervical Plate System (2019), cited by 1

## Recent decisions
- K232218: Zenius™ Spinal System (Aug 24, 2023)
- K230301: Athena III Cervical Plate System (Mar 7, 2023)
- K223654: Medussa-PL Cage (Dec 28, 2022)
- K200283: Medussa-PL Cage (Jun 18, 2020)
- K183407: Triton Cage (Aug 30, 2019)
- K183409: Athena II Cervical Plate System (Feb 11, 2019)
- K181978: Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (Aug 13, 2018)
- K180022: Athena Cervical Plate System (Jul 20, 2018)

Source page: https://510kreport.com/company/medyssey-usa