NUVASIVE COROENT SYSTEM
FDA 510(k) clearance K043405 · decided 2005-02-07
Clearance details
- K-number
- K043405
- Device name
- NUVASIVE COROENT SYSTEM
- Applicant
- Nuvasive, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-10
- Decision date
- 2005-02-07
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- MQP
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Pain Pump 2 Luer Cap, REF 525-401, Rx, Sterile, Product of Ireland Manufactured fo recall (Z-2356-2010) | Stryker Instruments Div. of Stryker Corporation | 2010-09-03 |
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 |