Zip Mis Interspinous Fusion System
FDA 510(k) K140715 · Aurora Spine, Inc.
510(k) numberK140715
Submission
- Device name
- Zip Mis Interspinous Fusion System
- Applicant
- Aurora Spine, Inc.
Washington, DC, US - Received
- March 21, 2014
- Decision date
- April 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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…
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| 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 |
| K232484 | KeyLift Expandable Interlaminar Stabilization SystemPEK · Traditional | Amplio Spine, LLC | 10/19/2023SE |
| 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 |
More from Spinal Simplicity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243865 | AERO MIS Facet Fusion SystemMRW · Traditional | 03/24/2025SE |
| K221047 | SILO TFX MIS Sacroiliac Joint Fixation SystemOUR · Traditional | 10/03/2022SE |
| K221399 | ZIP MIS Interspinous Fusion SystemPEK · Traditional | 07/08/2022SE |
| K220610 | Solo-LOVD · Traditional | 05/27/2022SE |
| K210521 | DEXA-C Cervical Interbody SystemODP · Traditional | 08/02/2021SE |
| K210325 | APOLLO Anterior Cervical Plate (ACP) SystemKWQ · Traditional | 03/23/2021SE |
| K141317 | Zip Mis Interspinous Fusion SystemPEK · Traditional | 11/17/2014SE |
| K133967 | Interbody Cage SystemMAX · Traditional | 01/31/2014SE |
| K133091 | Zip Mis Interspinous Fusion SystemPEK · Traditional | 11/27/2013SE |
Questions and answers
When was Zip Mis Interspinous Fusion System cleared by the FDA?
Zip Mis Interspinous Fusion System (K140715) received a 510(k) decision of Substantially Equivalent on April 17, 2014, 27 days after the submission was received.
What is the product code of K140715?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.