510(k) K013215
- Device
- MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
- Applicant
- NUVASIVE, INC.
- 510(k) number
- K013215
- Product code
- BXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-16
- Date received
- 2001-09-26
- Regulation
- 868.2775
- Classification name
- Stimulator, Nerve, Ac-powered
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SEAN M CURRY
- Address
- 10065 Old Grove Rd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 2032098
- 2031966
- 3030412764
- 2011115
Source Documents#
Other 510(k) Records For Product Code BXM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002677 | NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | 2000-11-13 |
| K921498 | VER MED A10011 PNS DUAL ELEMENT ELECTRODE | Vermont Medical, Inc. | 1993-06-09 |
| K870662 | MODEL SKCK STERILE KNOB COVER KIT | Life-Tech Intl., Inc. | 1987-10-28 |
Legacy Summary#
summary
FDA Review#
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