NAVIOPFS— 510(k) K121936
Substantially EquivalentBlue Belt Technologies, Inc.
FDA 510(k) clearance K121936 for NAVIOPFS, Substantially Equivalent on 2012-11-30. Applicant: Blue Belt Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Blue Belt Technologies, Inc.
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Recent devices under product code OLO
view allMore clearances from Blue Belt Technologies, Inc.
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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 →
Recalls naming K121936
K-number listed on FDA's recall record- Z-1634-2020 — NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.
- Z-1575-2014 — NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121936.
Data sourced from openFDA. This site is unofficial and independent of the FDA.