Synthes Navigable Pedicle Preparation Instruments
FDA 510(k) K122211 · Synthes Spine
510(k) numberK122211
Submission
- Device name
- Synthes Navigable Pedicle Preparation Instruments
- Applicant
- Synthes Spine
West Chester, PA, US - Received
- July 25, 2012
- Decision date
- December 17, 2012
- 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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| 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 |
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| K120838 | Synthes Matrix SystemNKB · Traditional | 07/31/2012SE |
| K121852 | Synthes Zero-P Variable Angle (Va)OVE · Special | 07/25/2012SE |
| K111048 | Synthes Scout Tack FixationOMR · Traditional | 06/14/2012SESU |
| K120928 | Synthes Matrix SystemNKB · Traditional | 05/18/2012SE |
| K120571 | Synthes Uss ConnectorNKB · Traditional | 05/14/2012SE |
| K113149 | Synthes Uss ConnectorsMNI · Traditional | 02/01/2012SE |
| K113044 | Synthes MirsNKB · Traditional | 12/21/2011SE |
| K112459 | Synthes Zero-POVE · Special | 12/12/2011SE |
| K111358 | Synthes UssNKB · Traditional | 11/18/2011SE |
| K112068 | Synthes Zero-P Variable Angle (Va)OVE · Traditional | 11/07/2011SE |
Questions and answers
When was Synthes Navigable Pedicle Preparation Instruments cleared by the FDA?
Synthes Navigable Pedicle Preparation Instruments (K122211) received a 510(k) decision of Substantially Equivalent on December 17, 2012, 145 days after the submission was received.
What is the product code of K122211?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.