← Back to catalogue

Evolution Spine Navigation Instruments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250167

by Evolution Spine

Identifiers

510(k) Number
K250167 FDA 510(k)
FDA Product Code
OLO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Evolution Spine Navigation Instruments by Evolution Spine — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Evolution Spine

Sources (1)

  • FDA 510(k) K250167 24 fields · synced Jun 18, 2026