X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
FDA 510(k) clearance K173787 · decided 2018-06-11
Clearance details
- K-number
- K173787
- Device name
- X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2017-12-14
- Decision date
- 2018-06-11
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- MQP
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lelocle, CH
- Third-party review
- No
- Expedited review
- No
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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.