Peridot Intervertebral body fusion System
FDA 510(k) K192026 · Gbs Commonwealth Co., Ltd.
510(k) numberK192026
Submission
- Device name
- Peridot Intervertebral body fusion System
- Applicant
- Gbs Commonwealth Co., Ltd.
Geumcheon-Gu, KR - Received
- July 29, 2019
- Decision date
- November 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…ODP · Special | 12/20/2023SE |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | 11/21/2023SE |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion SystemMAX · Traditional | 11/07/2023SE |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…ODP · Special | 10/13/2023SE |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…ODP · Traditional | 05/22/2023SE |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | 02/17/2023SE |
| K213980 | Peridot Spinal Interbody SystemODP · Traditional | 03/15/2022SE |
| K211205 | Prase-C Anterior Cervical Plate SystemKWQ · Traditional | 08/12/2021SE |
| K202872 | Prase PEEK Anterior Cervical Interbody SpacerODP · Traditional | 02/04/2021SE |
| K202878 | Prase-AP Anterior Cervical Plate SystemKWQ · Traditional | 01/29/2021SE |
Questions and answers
When was Peridot Intervertebral body fusion System cleared by the FDA?
Peridot Intervertebral body fusion System (K192026) received a 510(k) decision of Substantially Equivalent on November 26, 2019, 120 days after the submission was received.
What is the product code of K192026?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.