Pediguard Nerve Detector System
FDA 510(k) K123390 · Spineguard S.A.
510(k) numberK123390
Submission
- Device name
- Pediguard Nerve Detector System
- Applicant
- Spineguard S.A.
Washington, DC, US - Received
- November 2, 2012
- Decision date
- August 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PDQ – Neurosurgical Nerve Locator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
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| K221821 | ATEC IOM Accessory InstrumentsPDQ · Traditional | Alphatec Spine, Inc. | 09/23/2022SE |
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| K201454 | DSG Connect TechnologyPDQ · Traditional | Spineguard S.A. | 02/10/2021SE |
| K191723 | ATEC IOM Accessory InstrumentsPDQ · Traditional | Alphatec Spine, Inc. | 10/18/2019SE |
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More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K220160 | PediGuard ThreadedPDQ · Traditional | 03/31/2022SE |
| K201454 | DSG Connect TechnologyPDQ · Traditional | 02/10/2021SE |
| K162884 | SpineGuard DSG Zavation Screw SystemHBG · Traditional | 01/12/2017SE |
| K152747 | DSG Threaded Drill SystemPDQ · Traditional | 06/10/2016SE |
| K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard…PDQ · Traditional | 01/23/2015SE |
Questions and answers
When was Pediguard Nerve Detector System cleared by the FDA?
Pediguard Nerve Detector System (K123390) received a 510(k) decision of Substantially Equivalent on August 8, 2013, 279 days after the submission was received.
What is the product code of K123390?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.