Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System— 510(k) K151648
Substantially EquivalentAltus Partners, LLC
FDA 510(k) clearance K151648 for Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System, Substantially Equivalent on 2015-10-16. Applicant: Altus Partners, LLC. Device class: 2.
Clearance details
- Applicant
- Altus Partners, LLC
- 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
- Newtown Square, PA, US
Recent devices under product code NKB
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- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Altus Partners, LLC
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.