Life Spine Laminoplasty System
FDA 510(k) K181717 · Life Spine, Inc.
510(k) numberK181717
Submission
- Device name
- Life Spine Laminoplasty System
- Applicant
- Life Spine, Inc.
Huntley, IL, US - Received
- June 28, 2018
- Decision date
- October 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQW – Orthosis, Spine, Plate, Laminoplasty, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Other 510(k)s with product code NQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252930 | AQUA Laminoplasty SystemsNQW · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
| K243137 | Curiteva Porous PEEK Laminoplasty SystemNQW · Special | Curiteva, Inc. | 10/28/2024SE |
| K242784 | Vy Spine VyLam Laminoplasty SystemNQW · Special | Vy Spine, LLC | 10/16/2024SE |
| K232471 | Vy Spine VyLam Laminoplasty SystemNQW · Traditional | Vy Spine, LLC | 10/10/2023SE |
| K231232 | Curiteva Laminoplasty SystemNQW · Traditional | Curiteva, Inc. | 06/28/2023SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | Medtronic Sofamor Danek | 12/13/2021SE |
| K191927 | Hinged Laminoplasty SystemNQW · Traditional | Life Spine, Inc. | 09/20/2019SE |
| K191169 | NuVasive® Camber Laminoplasty SystemNQW · Traditional | Nu Vasive, Incorporated | 07/03/2019SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | Choicespine, LP | 01/19/2018SE |
| K171413 | HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation SystemNQW · Traditional | Globus Medical, Inc. | 07/14/2017SE |
More from Globus Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261430 | TruLift Expandable SystemMAX · Traditional | 07/28/2026SE |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsOLO · Traditional | 06/02/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | 05/12/2026SE |
| K254274 | ARx® SAI Implant SystemNKB · Traditional | 04/16/2026SE |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemMAX · Traditional | 01/23/2026SE |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemMAX · Traditional | 07/07/2025SE |
| K250373 | ProLift Expandable Spacer SystemMAX · Traditional | 04/09/2025SE |
| K243668 | ProLift Pivot Expandable Spacer SystemMAX · Traditional | 01/23/2025SE |
| K243369 | Cervical Plating SystemKWQ · Traditional | 12/11/2024SE |
| K242826 | ProLift Wedge Expandable Spacer SystemMAX · Traditional | 10/08/2024SE |
Questions and answers
When was Life Spine Laminoplasty System cleared by the FDA?
Life Spine Laminoplasty System (K181717) received a 510(k) decision of Substantially Equivalent on October 12, 2018, 106 days after the submission was received.
What is the product code of K181717?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.