NuVasive Next Generation NVM5 System
FDA 510(k) K162313 · Nu Vasive, Incorporated
510(k) numberK162313
Submission
- Device name
- NuVasive Next Generation NVM5 System
- Applicant
- Nu Vasive, Incorporated
San Diego, CA, US - Received
- August 18, 2016
- Decision date
- March 16, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K221388 | NuVasive Reline Cervical SystemNKG · Traditional | 09/09/2022SE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional | 06/21/2022SE |
| K213654 | NuVasive Reline Cervical SystemNKG · Traditional | 02/23/2022SE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional | 12/23/2021SE |
| K212446 | NuVasive Anterior Cervical Plate SystemsKWQ · Traditional | 11/03/2021SE |
Questions and answers
When was NuVasive Next Generation NVM5 System cleared by the FDA?
NuVasive Next Generation NVM5 System (K162313) received a 510(k) decision of Substantially Equivalent on March 16, 2017, 210 days after the submission was received.
What is the product code of K162313?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.