Exactech GPS
FDA 510(k) K152764 · Blue Ortho
510(k) numberK152764
Submission
- Device name
- Exactech GPS
- Applicant
- Blue Ortho
La Tronche, FR - Received
- September 24, 2015
- Decision date
- July 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
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| 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 |
|---|---|---|
| K233299 | ExactechGPS® SystemOLO · Traditional | 01/26/2024SE |
| K232521 | ExactechGPS® Total Ankle ApplicationOLO · Traditional | 11/16/2023SE |
| K213877 | ExactechGPS® SystemOLO · Traditional | 05/02/2022SE |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareOLO · Traditional | 01/06/2022SE |
| K193618 | ExactechGPS SystemOLO · Traditional | 09/02/2020SE |
| K173372 | ExactechGPS Total Shoulder ApplicationOLO · Special | 11/24/2017SE |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareOLO · Traditional | 04/05/2017SE |
| K100742 | Exactech GPSOLO · Traditional | 10/21/2010SE |
Questions and answers
When was Exactech GPS cleared by the FDA?
Exactech GPS (K152764) received a 510(k) decision of Substantially Equivalent on July 13, 2016, 293 days after the submission was received.
What is the product code of K152764?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.