NUVASIVE MESH
FDA 510(k) clearance K020853 · decided 2002-06-13
Clearance details
- K-number
- K020853
- Device name
- NUVASIVE MESH
- Applicant
- Nuvasive, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-15
- Decision date
- 2002-06-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- EZX
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K023882) | Implex Corp. | 2003-02-19 |
| SYNTHES SYNMESH (K983766) | Synthes (Usa) | 1998-12-18 |
| TROCHANTER MESH (K945027) | Acu Med, Inc. | 1995-02-01 |
| MOTECH TITANIUM SURGICAL MESH (K900138) | Biedermann Motech GmbH | 1990-03-20 |
| TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (K896369) | Techmedica, Inc. | 1989-11-24 |
| STUART TITANIUM SURGICAL MESH (K890601) | Stuart | 1989-03-16 |
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 |