Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system— 510(k) K233084
Substantially EquivalentGbs Commonwealth Co., Ltd.
FDA 510(k) clearance K233084 for Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system, Substantially Equivalent on 2023-11-21. Applicant: Gbs Commonwealth Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Gbs Commonwealth Co., Ltd.
- Product code
- Code ODP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geumcheon-Gu, KR
Recent devices under product code ODP
view allMore clearances from Gbs Commonwealth Co., Ltd.
view all- K233839 — Peridot-PT Anterior Cervical Intervertebral body fusion System +3 more
- K232292 — Peridot-EX Expandable Intervertebral Body Fusion System
- K232822 — 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 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) +1 more
- K213755 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
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.