Nuvasive INS-1 Intraoperative Nerve Surveillance System
FDA 510(k) K002677 · Nuvasive, Inc.
510(k) numberK002677
Submission
- Device name
- Nuvasive INS-1 Intraoperative Nerve Surveillance System
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- August 28, 2000
- Decision date
- November 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BXM – Stimulator, Nerve, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
Other 510(k)s with product code BXM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013215 | Modified INS-1 Intraoperative Nerve Surveillance SystemBXM · Special | Nuvasive, Inc. | 10/16/2001SE |
| K921498 | Ver Med A10011 PNS Dual Element ElectrodeBXM · Traditional | Vermont Medical, Inc. | 06/09/1993SE |
| K870662 | Model SKCK Sterile Knob Cover KitBXM · Traditional | Life-Tech Intl., Inc. | 10/28/1987SE |
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Questions and answers
When was Nuvasive INS-1 Intraoperative Nerve Surveillance System cleared by the FDA?
Nuvasive INS-1 Intraoperative Nerve Surveillance System (K002677) received a 510(k) decision of Substantially Equivalent on November 13, 2000, 77 days after the submission was received.
What is the product code of K002677?
The FDA product code is BXM – Stimulator, Nerve, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.