Seaspine Spacer System
FDA 510(k) K102026 · Seaspine, Inc.
510(k) numberK102026
Submission
- Device name
- Seaspine Spacer System
- Applicant
- Seaspine, Inc.
Vista, CA, US - Received
- July 19, 2010
- Decision date
- May 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
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| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
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| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 Seaspine Spacer System cleared by the FDA?
Seaspine Spacer System (K102026) received a 510(k) decision of Substantially Equivalent on May 12, 2011, 297 days after the submission was received.
What is the product code of K102026?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.