X-MESH EXPANDABLE CAGE SYSTEM
FDA 510(k) clearance K080568 · decided 2008-05-01
Clearance details
- K-number
- K080568
- Device name
- X-MESH EXPANDABLE CAGE SYSTEM
- Applicant
- Depuy Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-29
- Decision date
- 2008-05-01
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- MQP
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Depuy Spine
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vertiwedge® Intraosseous System (K261810) | Foundation Surgical Group | 2026-07-31 |
| POSEIDON ST (K261031) | Signus Medinzintechnik GmbH | 2026-07-10 |
| VyBrate™ VBR System (K253158) | Vy Spine, LLC | 2026-01-07 |
| Vertiwedge® Intraosseous System (K241468) | Foundation Surgical Group, Inc. | 2024-11-07 |
| KONG®-TL VBR System and KONG® C VBR System (K232790) | Icotec AG | 2024-04-04 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IN MOTION LUMBAR ARTIFICIAL DISC (P040006/S005) | Depuy Spine, Inc. | 2011-02-08 |
| IN MOTION ARTIFICIAL DISC (P040006/S004) | Depuy Spine, Inc. | 2007-09-05 |
| CHARITE ARTIFICIAL DISC (P040006/S003) | Depuy Spine, Inc. | 2006-12-15 |
| CHARITE ARTIFICIAL DISC (P040006/S002) | Depuy Spine, Inc. | 2006-03-29 |
| CHARITE ARTIFICIAL DISC (P040006/S001) | Depuy Spine, Inc. | 2005-06-16 |
| CHARITE ARTIFICIAL DISC (P040006) | Depuy Spine, Inc. | 2004-10-26 |
| LUMBAR I/F CAGE SYSTEM (P960025/S010) | Depuy Spine, Inc. | 2004-03-17 |
| SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE (P960025/S011) | Depuy Spine, Inc. | 2004-03-05 |