Navipro
FDA 510(k) K020764 · Kinamed, Inc.
510(k) numberK020764
Submission
- Device name
- Navipro
- Applicant
- Kinamed, Inc.
Camarillo, CA, US - Received
- March 7, 2002
- Decision date
- June 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
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| K122049 | Neuropro Low Profile Cranial Plating SystemGWO · Traditional | 04/05/2013SE |
| K102834 | Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)JDQ · Special | 01/12/2011SE |
| K072250 | Supercable Grip and Plate SystemKTT · Traditional | 11/09/2007SE |
| K050897 | Navipro Shoulder Software ModuleHAW · Traditional | 05/24/2005SE |
| K033668 | Navipro Knee Software ModuleHAW · Traditional | 03/11/2004SE |
| K032950 | Gem Inset Patellar ComponentJWH · Traditional | 12/19/2003SE |
| K030256 | Iso-Elastic Cerclage SystemJDQ · Traditional | 10/21/2003SE |
| K013982 | Kinematch Patello-Femoral Resurfacing ImpalantKRR · Traditional | 05/21/2002SE |
| K010101 | Gem Posterior Stabilized Total Knee SystemJWH · Traditional | 05/17/2001SE |
Questions and answers
When was Navipro cleared by the FDA?
Navipro (K020764) received a 510(k) decision of Substantially Equivalent on June 3, 2002, 88 days after the submission was received.
What is the product code of K020764?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.