Integrity Implants Navigated Instruments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212088

Identifiers

510(k) Number: K212088 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)

A comprehensive medical device that provides accurate and reliable data on neurological disorders, offering a user-friendly interface and robust analytics capabilities. The device's advanced algorithms enable users to track changes in their condition over time, providing valuable insights for diagnosis and treatment planning.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K212088	Class II	Active

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Manufacturer

Manufacturer: Integrity Implants Inc.
FDA Applicant: Integrity Implants, Inc.

Sources (1)

FDA 510(k) K212088 24 fields · synced Jul 27, 2026