MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
FDA 510(k) clearance K013215 · decided 2001-10-16
Clearance details
- K-number
- K013215
- Device name
- MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
- Applicant
- Nuvasive, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-26
- Decision date
- 2001-10-16
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- BXM
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K002677) | Nuvasive, Inc. | 2000-11-13 |
| VER MED A10011 PNS DUAL ELEMENT ELECTRODE (K921498) | Vermont Medical, Inc. | 1993-06-09 |
| MODEL SKCK STERILE KNOB COVER KIT (K870662) | Life-Tech Intl., Inc. | 1987-10-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Simplify® Cervical Artificial Disc (P200022/S016) | Nuvasive, Inc. | 2025-06-05 |
| Simplify® Cervical Artificial Disc (P200022/S017) | Nuvasive, Inc. | 2025-05-29 |
| Simplify Disc (P200022/S012) | Nuvasive, Inc. | 2025-02-18 |
| Simplify Cervical Artificial Disc (P200022/S015) | Nuvasive, Inc. | 2025-02-13 |
| Simplify Cervical Artificial Disc (P200022/S014) | Nuvasive, Inc. | 2024-12-18 |
| Simplify® Cervical Artificial Disc (P200022/S013) | Nuvasive, Inc. | 2024-04-17 |
| Simplify Disc (P200022/S011) | Nuvasive, Inc. | 2023-06-09 |
| Simplify Cervical Artificial Disc (P200022/S010) | Nuvasive, Inc. | 2023-03-15 |