CUTTING EDGE SPINE

FDA Device Registration & Listing · Mineral Spgs, NC, US · Registration 3009129735

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009129735
FEI Number
3009129735
Entity Name
CUTTING EDGE SPINE
City/State/Country
Mineral Spgs, NC, US
Establishment Address
6012 Waxhaw Highway, Mineral Spgs, NC 28108, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Cutting Edge Spine (Owner Number: 10036880)
Owner / Operator Contact Address
6012 Waxhaw hwy, Mineral Springs, NC 28108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180891
PMA Number
N/A

All Registered Proprietary Names

T-FIX™3Dsi Joint Fusion System EVOS Lumbar Interbody System EVOL®ha-C Cervical Interbody System EVOL®ha-D Lateral Interbody Fusion System EVOS Lumbar Interbody System EVOLha-LIF Interbody System EVOL® Lumbar Interbody System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-07-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-09-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-08-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-12-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-08-01

Official Correspondent

Brad Roof

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cutting Edge Spine
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K213667 SI-BONE, Inc. iFuse-TORQ® Implant System 2022-06-10
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09

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3012103114 SI-TECHNOLOGY, LLC Woodstock, GA, US
3004499989 LIFE SPINE Huntley, IL, US
3010143171 AR FABRICATING Georgetown, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009129735. Last updated year: 2026. Please use registration number 3009129735 when referencing this establishment in official correspondence.
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