NuVasive PEEK Corpectomy Railed System
FDA 510(k) clearance K151538 · decided 2015-09-04
Clearance details
- K-number
- K151538
- Device name
- NuVasive PEEK Corpectomy Railed System
- Applicant
- Nu Vasive, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2015-06-08
- Decision date
- 2015-09-04
- Days to decision
- 88 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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| Record | Firm | Date |
|---|---|---|
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| DOMINION Expandable Corpectomy System (K233359) | Astura Medical | 2024-03-08 |
| VerteLoc Spinal System (K231134) | Signature Orthopaedics Pty, Ltd. | 2024-02-13 |
| Ascend VBR System, Ascend NanoTec VBR System (K232173) | Alphatec Spine, Inc. | 2023-10-06 |
| ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (K211892) | Arftx Medical, LLC | 2022-10-06 |
| F3D Corpectomy System (K202637) | Corelink, LLC | 2020-12-23 |
| KONG-TL VBR System, KONG-C VBR System (K200235) | Icotec AG | 2020-05-29 |
| NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System (K193506) | Nu Vasive, Incorporated | 2020-02-26 |
Recalls involving this device
No recalls on record reference this clearance.