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— 510(k) K233839
Substantially EquivalentGbs Commonwealth Co., Ltd.
FDA 510(k) clearance K233839 for 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, Substantially Equivalent on 2023-12-20. Applicant: Gbs Commonwealth Co., Ltd..
Clearance details
- Applicant
- Gbs Commonwealth Co., Ltd.
- Product code
- Code ODP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Geumcheon-Gu, KR
Adverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
Source: openFDA MAUDE database, through . 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.