KeyLift Expandable Interlaminar Stabilization System
FDA 510(k) K232484 · Amplio Spine, LLC
510(k) numberK232484
Submission
- Device name
- KeyLift Expandable Interlaminar Stabilization System
- Applicant
- Amplio Spine, LLC
Boca Raton, FL, US - Received
- August 16, 2023
- Decision date
- October 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEK – Spinous Process Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Other 510(k)s with product code PEK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253250 | Minuteman® G6 MIS Fusion PlatePEK · Traditional | Spinal Simplicity, LLC | 12/01/2025SE |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…PEK · Special | Spinal Simplicity, LLC | 01/18/2024SE |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…PEK · Special | Spinal Simplicity, LLC | 11/29/2023SE |
| K231807 | primaLOK SP Interspinous Fusion SystemPEK · Traditional | Wenzel Spine, Inc. | 08/15/2023SE |
| K223790 | Huvex Interspinous Fusion SystemPEK · Traditional | Dio Medical Corp. | 03/09/2023SE |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…PEK · Traditional | Spinal Simplicity, LLC | 08/19/2022SE |
| K221399 | ZIP MIS Interspinous Fusion SystemPEK · Traditional | Aurora Spine, Inc. | 07/08/2022SE |
| K211880 | Minuteman G5 MIS Fusion PlatePEK · Traditional | Spinal Simplicity, LLC | 03/11/2022SE |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…PEK · Traditional | Spinal Simplicity, LLC | 12/15/2021SE |
| K213266 | Inspan ScrewLES Fusion SystemPEK · Traditional | Lespine Innovations, LLC | 12/03/2021SE |
Questions and answers
When was KeyLift Expandable Interlaminar Stabilization System cleared by the FDA?
KeyLift Expandable Interlaminar Stabilization System (K232484) received a 510(k) decision of Substantially Equivalent on October 19, 2023, 64 days after the submission was received.
What is the product code of K232484?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.