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)
Description
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) by Gbs Commonwealth Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230708
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 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) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion Sys... | Gbs Commonwealth Co., Ltd. | 2023 |
| K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022 |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacific... | SeaSpine Orthopedics Corporation | 2021 |
| K200551 | MectaLIF Transforaminal TiPEEK | Medacta Inernational SA | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral bod... | Gbs Commonwealth Co., Ltd. | 2023 |
Trace the full predicate network for K230708
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.