# Gbs Commonwealth Co., Ltd.

- Location (FDA's records): Geumcheon-Gu, KR
- FDA decisions: 14 (2018–2023): 14 510(k) clearances
- Product codes: ODP (7), NKB (3), MAX (2), KWQ (2)
- 510(k) review time since 2016: median 92 days, against 107 for FDA's reviews in the same codes and years (6 of 14 faster)
- Predicates its devices cite: 39 (15 its own); citations of its devices by later devices: 16 (15 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
- L&K BIOMED Co., Ltd.: 6 (https://510kreport.com/company/l-k-biomed)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Nu Vasive, Incorporated: 3 (https://510kreport.com/company/nu-vasive)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)
- MiRus, LLC: 1 (https://510kreport.com/company/mirus)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Medacta Inernational SA: 1 (https://510kreport.com/company/medacta-inernational)

## Firms that cite its devices most
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)

## Its most-cited devices
- K213755: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system (2023), cited by 3
- K173645: JASPER Spinal Fixation System (2018), cited by 2
- K192026: Peridot Intervertebral body fusion System (2019), cited by 2
- K202878: Prase-AP Anterior Cervical Plate System (2021), cited by 1
- K233839: Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system (2023), cited by 1
- K182059: Prase MIS Spinal System (2018), cited by 1

## Recent decisions
- K233839: Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system (Dec 20, 2023)
- K233084: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system (Nov 21, 2023)
- K232292: Peridot-EX Expandable Intervertebral Body Fusion System (Nov 7, 2023)
- K232822: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (Oct 13, 2023)
- K230708: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (May 22, 2023)
- K213755: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system (Feb 17, 2023)
- K213980: Peridot Spinal Interbody System (Mar 15, 2022)
- K211205: Prase-C Anterior Cervical Plate System (Aug 12, 2021)

Source page: https://510kreport.com/company/gbs-commonwealth