FDA Product Code
FDA Product Code PEK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3050
510(k) Clearances — 49 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261607 | Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System | Spinal Simplicity, LLC | 2026-10-02 | Traditional | PDF ↗ |
| K253250 | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | 2025-12-01 | Traditional | PDF ↗ |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Spinal Simplicity, LLC | 2024-01-18 | Special | PDF ↗ |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2023-11-29 | Special | PDF ↗ |
| K232484 | KeyLift Expandable Interlaminar Stabilization System | Amplio Spine, LLC | 2023-10-19 | Traditional | PDF ↗ |
| K231807 | primaLOK SP Interspinous Fusion System | Wenzel Spine, Inc. | 2023-08-15 | Traditional | PDF ↗ |
| K223790 | Huvex Interspinous Fusion System | Dio Medical Corp. | 2023-03-09 | Traditional | PDF ↗ |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | Spinal Simplicity, LLC | 2022-08-19 | Traditional | PDF ↗ |
| K221399 | ZIP MIS Interspinous Fusion System | Aurora Spine, Inc. | 2022-07-08 | Traditional | PDF ↗ |
| K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | 2022-03-11 | Traditional | PDF ↗ |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity, LLC | 2021-12-15 | Traditional | PDF ↗ |
| K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | 2021-12-03 | Traditional | PDF ↗ |
| K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020-12-10 | Traditional | PDF ↗ |
| K201704 | CoFix System | Paradigm Spine GmbH | 2020-08-04 | Special | PDF ↗ |
| K182352 | SP-LINK System | Medical Designs, LLC | 2018-11-21 | Traditional | PDF ↗ |
| K180817 | AERIAL Interspinous Fixation | Globus Medical, Inc. | 2018-05-21 | Traditional | PDF ↗ |
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018-03-07 | Traditional | PDF ↗ |
| K173334 | SeaSpine Spinous Process System | SeaSpine Orthopedics Corporation | 2018-02-22 | Traditional | PDF ↗ |
| K163471 | Kalitec Direct InSePtion MIS Fixation System | Kalitec Direct, LLC | 2017-03-16 | Traditional | PDF ↗ |
| K162849 | Huvex Interspinous Fixation System | Dio Medical Co., Ltd. | 2017-02-16 | Traditional | PDF ↗ |
| K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017-02-02 | Special | PDF ↗ |
| K161016 | Z-Clamp ISP System | Zavation, LLC | 2016-10-19 | Traditional | PDF ↗ |
| K153302 | coflex-IF | Paradigm Spine, LLC | 2016-09-08 | Traditional | PDF ↗ |
| K160465 | Spinal Elements' Spinous Process Plate System | Spinal Elements, Inc. | 2016-07-28 | Traditional | PDF ↗ |
| K160568 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2016-05-04 | Traditional | PDF ↗ |
| K143631 | Benefix Interspinous Fixation System | U&I Corporation | 2015-09-03 | Traditional | PDF ↗ |
| K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015-08-20 | Traditional | PDF ↗ |
| K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2015-08-07 | Special | PDF ↗ |
| K142217 | Reliance Interspinous Plate System | Reliance Medical Systems, LLC | 2015-04-02 | Traditional | PDF ↗ |
| K143388 | Affix IIS Spinous Process Plate System | Nu Vasive, Incorporated | 2015-03-05 | Traditional | PDF ↗ |
| K140046 | SPINOUS PROCESS FUSION (SPF) PLATE | Spinal Simplicity, LLC | 2015-01-09 | Traditional | PDF ↗ |
| K142378 | Interspinous Plate System | Precision Spine, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K141317 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Aurora Spine, Inc. | 2014-11-17 | Traditional | PDF ↗ |
| K140236 | AILERON INTERSPINOUS FIXATION SYSTEM | Life Spine, Inc. | 2014-10-20 | Traditional | PDF ↗ |
| K142213 | VIA SPINOUS PROCESS FIXATION SYSTEM | Spineology, Inc. | 2014-09-10 | Special | PDF ↗ |
| K141508 | ROMEO 2 PAD POSTERIOR AXIAL DEVICE | Spineart | 2014-08-21 | Traditional | PDF ↗ |
| K132765 | PFX SPINOUS PROCESS FIXATION SYSTEM | Innovasis, Inc. | 2014-07-14 | Traditional | PDF ↗ |
| K140715 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Aurora Spine, Inc. | 2014-04-17 | Special | PDF ↗ |
| K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | Ldr Spine USA, Inc. | 2014-03-07 | Traditional | PDF ↗ |
| K133052 | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM | Nuvasive, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K133091 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Aurora Spine | 2013-11-27 | Traditional | PDF ↗ |
| K132191 | SP-FIX SPINOUS PROCESS FIXATION PLATE | Globus Medical, Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K132411 | AFFIX II SPINOUS PROCESS PLATE SYSTEM | Nu Vasive, Incorporated | 2013-11-20 | Traditional | PDF ↗ |
| K132968 | UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) | Stryker Spine | 2013-11-18 | Traditional | PDF ↗ |
| K130066 | SPECTRUM SPINE SPINOUS PROCESS DEVICE | Spectrum Spine IP Holdings, LLC | 2013-11-12 | Traditional | PDF ↗ |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | Seaspine, Inc. | 2013-09-04 | Traditional | PDF ↗ |
| K124014 | SUREFIX INTERSPINOUS FUSION SYSTEM | Jg Spine, LLC | 2013-08-09 | Traditional | PDF ↗ |
| K131238 | AFFIX SPINOUS PROCESS PLATE SYSTEM | Nuvasive, Inc. | 2013-07-02 | Traditional | PDF ↗ |
| K130438 | AXLE INTERSPINOUS FUSION SYSTEM | X-Spine Systems, Inc. | 2013-06-27 | Traditional | PDF ↗ |
Product code PEK · Class II · Orthopedic. Data: openFDA.