Prase-AP Anterior Cervical Plate System— 510(k) K202878
Substantially EquivalentGbs Commonwealth Co., Ltd.
FDA 510(k) clearance K202878 for Prase-AP Anterior Cervical Plate System, Substantially Equivalent on 2021-01-29. Applicant: Gbs Commonwealth Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Gbs Commonwealth Co., Ltd.
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geumcheon-Gu, KR
Recent devices under product code KWQ
view allMore clearances from Gbs Commonwealth Co., Ltd.
view all- K233839 — Peridot-PT Anterior Cervical Intervertebral body fusion System +3 more
- K233084 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
- 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
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.