Zuma
FDA 510(k) K071726 · Seaspine, Inc.
510(k) numberK071726
Submission
- Device name
- Zuma
- Applicant
- Seaspine, Inc.
Vista, CA, US - Received
- June 25, 2007
- Decision date
- October 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
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|---|---|---|
| K231654 | NorthStar OCT SystemNKG · Traditional | 08/03/2023SE |
| K212135 | Dry DBM- A PuttyMQV · Traditional | 10/04/2021SE |
| K150469 | Integra Laminoplasty SystemNQW · Special | 03/23/2015SE |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…MAX · Traditional | 12/18/2014SE |
| K133418 | Integra Expandable Interverebral Body Fusion Device (Ibd) SystemMAX · Traditional | 05/01/2014SE |
| K132859 | Integra Facet Fixation SystemMRW · Traditional | 11/18/2013SE |
| K121924 | Integra Interspinous Process SystemPEK · Traditional | 09/04/2013SE |
| K130830 | Integra Laminoplasty SystemNQW · Traditional | 05/09/2013SE |
| K122571 | Malibu Spinal System with the Daytona Deformity SystemNKB · Special | 12/12/2012SE |
| K112206 | Cardiff Anterior Cervical Plate SystemKWQ · Special | 01/25/2012SE |
Questions and answers
When was Zuma cleared by the FDA?
Zuma (K071726) received a 510(k) decision of Substantially Equivalent on October 23, 2007, 120 days after the submission was received.
What is the product code of K071726?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.