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)— 510(k) K232822

Substantially Equivalent

Gbs Commonwealth Co., Ltd.

FDA 510(k) clearance K232822 for 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), Substantially Equivalent on 2023-10-13. Applicant: Gbs Commonwealth Co., Ltd..

Clearance details

Applicant: Gbs Commonwealth Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2023-09-13
Decision date: 2023-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Geumcheon-Gu, KR

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.