Innovasis Navigation Instruments— 510(k) K250182
Substantially EquivalentInnovasis, Inc.
FDA 510(k) clearance K250182 for Innovasis Navigation Instruments, Substantially Equivalent on 2025-03-24. Applicant: Innovasis, Inc.. Device class: 2.
Clearance details
- Applicant
- Innovasis, 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
- Salt Lake City, UT, US
Recent devices under product code OLO
view allMore clearances from Innovasis, Inc.
view all- K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- K241276 — Vector Pedicle Screw System
- K231899 — HAtetracell-C Titanium Cervical IBF System
- K223511 — Excella Navigation Instruments
- K223510 — Matrix HA Fusion Porous Cervical IBF System
Adverse 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 K250182
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250182.
Data sourced from openFDA. This site is unofficial and independent of the FDA.