Life Spine
Huntley, IL, US
LIFE SPINE appears in FDA device records in Huntley, IL. FDA records list 123 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 123FDA records hold 123 510(k) clearances for Life Spine between 2004 and 2026. The busiest year on record is 2015, with 10. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2006 | 6 |
| 2007 | 3 |
| 2008 | 6 |
| 2009 | 5 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 5 |
| 2013 | 7 |
| 2014 | 5 |
| 2015 | 10 |
| 2016 | 6 |
| 2017 | 10 |
| 2018 | 10 |
| 2019 | 7 |
| 2020 | 9 |
| 2021 | 6 |
| 2022 | 5 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261430 | TruLift Expandable System | MAX | Substantially Equivalent | |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | OLO | Substantially Equivalent | |
| K260837 | VersaLift Expandable System | MAX | Substantially Equivalent | |
| K254274 | ARx® SAI Implant System | NKB | Substantially Equivalent | |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | MAX | Substantially Equivalent | |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | MAX | Substantially Equivalent | |
| K250373 | ProLift Expandable Spacer System | MAX | Substantially Equivalent | |
| K243668 | ProLift Pivot Expandable Spacer System | MAX | Substantially Equivalent | |
| K243369 | Cervical Plating System | KWQ | Substantially Equivalent | |
| K242826 | ProLift Wedge Expandable Spacer System | MAX | Substantially Equivalent | |
| K241464 | ARx® SAI Implant System | OUR | Substantially Equivalent | |
| K233455 | ARx MIS Spinal Screw System | NKB | Substantially Equivalent | |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | MAX | Substantially Equivalent | |
| K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | OVE | Substantially Equivalent | |
| K223430 | ProLift Micro Expandable Spacer System | MAX | Substantially Equivalent | |
| K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | MAX | Substantially Equivalent | |
| K222628 | Life Spine ALIF Buttress Plate System | KWQ | Substantially Equivalent | |
| K213417 | Ghost Spacer System | MAX | Substantially Equivalent | |
| K220341 | ARx Modular Spinal System | NKB | Substantially Equivalent | |
| K220025 | ARx® Spinal System | NKB | Substantially Equivalent | |
| K212903 | SIMPACT Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | |
| K212520 | ProLift Micro Expandable Spacer System | MAX | Substantially Equivalent | |
| K202836 | GX Navigation Instrument System | OLO | Substantially Equivalent | |
| K210061 | ProLift Lateral HELO Fixated | MAX | Substantially Equivalent | |
| K210549 | ARx Spinal System | NKB | Substantially Equivalent | |
| K203361 | ProLift Wedge Expandable Spacer System | MAX | Substantially Equivalent | |
| K203163 | ARx Illiac Spinal Screw System | NKB | Substantially Equivalent | |
| K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | |
| K201721 | TruLift Expandable Spacer System | MAX | Substantially Equivalent | |
| K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | MAX | Substantially Equivalent | |
| K200896 | Solstice CCI | NKG | Substantially Equivalent | |
| K200070 | ARx Spinal System | NKB | Substantially Equivalent | |
| K200338 | ProLift Lateral Fixated | OVD | Substantially Equivalent | |
| K193521 | Steerable Plateau Ti | MAX | Substantially Equivalent | |
| K193258 | ProLift Expandable System | MAX | Substantially Equivalent | |
| K191834 | Stand-Alone ALIF Titanium System | OVD | Substantially Equivalent | |
| K190721 | LongBow Ti | MAX | Substantially Equivalent | |
| K191927 | Hinged Laminoplasty System | NQW | Substantially Equivalent | |
| K191575 | ARx Spinal System | NKB | Substantially Equivalent | |
| K190488 | ProLift Expandable System | MAX | Substantially Equivalent | |
| K191005 | ProLift® Expandable System | MAX | Substantially Equivalent | |
| K183430 | Modular Spinal Fixation System | NKB | Substantially Equivalent | |
| K181625 | Life Spine Resolute™ Threaded Cage System | MAX | Substantially Equivalent | |
| K182470 | Plateau Spacer System | MAX | Substantially Equivalent | |
| K181717 | Life Spine Laminoplasty System | NQW | Substantially Equivalent | |
| K180215 | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System | OVD | Substantially Equivalent | |
| K173883 | External Fixation System | KTT | Substantially Equivalent | |
| K180166 | Life Spine Lumbar Fixation System (SENTRY) | KWQ | Substantially Equivalent | |
| K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | |
| K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | OVE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004499989 | 3004499989 | LIFE SPINE | 13951 Quality Dr, Huntley, IL 60142 US | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- FZSCurette, Surgical, General Use
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- JDKProsthesis, Hip, Cement Restrictor
- KWDProsthesis, Toe, Hemi-, Phalangeal
- GADRetractor
- OURSacroiliac Joint Fixation
- HWCScrew, Fixation, Bone
- PEKSpinous Process Plate
- FMFSyringe, Piston
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain