Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System— 510(k) K172107
Substantially EquivalentSpineology, Inc.
FDA 510(k) clearance K172107 for Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System, Substantially Equivalent on 2017-08-21. Applicant: Spineology, Inc.. Device class: 2.
Clearance details
- Applicant
- Spineology, 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
- St. Paul, MN, US
Recent devices under product code NKB
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- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Spineology, 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.