Stryker Navigation System - Cranial Module, Model 6000-650-000
FDA 510(k) K062640 · Stryker Instruments
510(k) numberK062640
Submission
- Device name
- Stryker Navigation System - Cranial Module, Model 6000-650-000
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- September 6, 2006
- Decision date
- December 14, 2006
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | 06/17/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | 05/08/2026SE |
| K252282 | SurgiCount+ SystemPBZ · Traditional | 03/16/2026SE |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…OLO · Traditional | 09/25/2025SE |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional | 09/09/2025SE |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional | 05/15/2025SE |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemGEI · Special | 04/15/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | 03/24/2025SE |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 ConsoleOLO · Traditional | 03/21/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | 03/11/2025SE |
Questions and answers
When was Stryker Navigation System - Cranial Module, Model 6000-650-000 cleared by the FDA?
Stryker Navigation System - Cranial Module, Model 6000-650-000 (K062640) received a 510(k) decision of Substantially Equivalent on December 14, 2006, 99 days after the submission was received.
What is the product code of K062640?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.