510(k) 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 by Gbs Commonwealth Co., Ltd. — Product Code ODP

K233839 is an FDA 510(k) premarket notification submitted by Gbs Commonwealth Co., Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Gbs Commonwealth Co., Ltd. has at least 10 other 510(k) clearances on record.