Reform Pedicle Screw System— 510(k) K150856
Substantially EquivalentPrecision Spine, Inc.
FDA 510(k) clearance K150856 for Reform Pedicle Screw System, Substantially Equivalent on 2015-07-07. Applicant: Precision Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Precision Spine, 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
- Special
- Location
- Pear, MS, US
Recent devices under product code NKB
view all- K253943 — Tiger 2 System
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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
- K253045 — Socko Vimax Spinal Fixation System
More clearances from Precision Spine, 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.