The JASPER Spinal Fixation System II— 510(k) K190762
Substantially EquivalentGbs Commonwealth Co., Ltd.
FDA 510(k) clearance K190762 for The JASPER Spinal Fixation System II, Substantially Equivalent on 2019-06-19. Applicant: Gbs Commonwealth Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Gbs Commonwealth Co., Ltd.
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geumcheon-Gu, KR
Recent devices under product code NKB
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- K230708 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) +1 more
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.