K232822

Substantially Equivalent

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.
Product 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

Download summary PDF View on FDA.gov ↗

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.