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)
FDA 510(k) K230708 · Gbs Commonwealth Co., Ltd.
510(k) numberK230708
Submission
- Device name
- 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)
- Applicant
- Gbs Commonwealth Co., Ltd.
Geumcheon-Gu, KR - Received
- March 14, 2023
- Decision date
- May 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 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 |
| 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 |
| K192026 | Peridot Intervertebral body fusion SystemMAX · Traditional | 11/26/2019SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K230708) received a 510(k) decision of Substantially Equivalent on May 22, 2023, 69 days after the submission was received.
What is the product code of K230708?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.