Swedge Pedicle Screw Fixation System— 510(k) K170045
Substantially EquivalentSpinal Resources, Inc.
FDA 510(k) clearance K170045 for Swedge Pedicle Screw Fixation System, Substantially Equivalent on 2017-06-26. Applicant: Spinal Resources, Inc.. Device class: 2.
Clearance details
- Applicant
- Spinal Resources, Inc.
- Product code
- 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
- Fort Lauderdale, FL, US
Recent devices under product code NKB
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- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
More clearances from Spinal Resources, Inc.
view allAdverse 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.