Cutting Edge Spine
Mineral Spgs, NC, US
CUTTING EDGE SPINE appears in FDA device records in Mineral Spgs, NC. FDA records list 11 510(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
FDA records hold 11 510(k) clearances for Cutting Edge Spine between 2011 and 2025. The busiest year on record is 2020, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2015 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250605 | EVOL® ha – Hyper C Cervical Interbody Fusion System | ODP | Substantially Equivalent | |
| K230689 | T-FIX™ 3DSI Joint Fusion System | OUR | Substantially Equivalent | |
| K214123 | T-FIX® 3DSI Joint Fusion System | OUR | Substantially Equivalent | |
| K200991 | EVOL Spinal Interbody System | MAX | Substantially Equivalent | |
| K200552 | EVOS Lumbar Interbody System | MAX | Substantially Equivalent | |
| K192497 | EVOL ha - D Lateral Interbody Fusion System | MAX | Substantially Equivalent | |
| K190025 | EVOL® -SI Joint Fusion System | OUR | Substantially Equivalent | |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | ODP | Substantially Equivalent | |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | MAX | Substantially Equivalent | |
| K150321 | EVOS Lumbar Interbody System | MAX | Substantially Equivalent | |
| K102957 | CUTTING EDGE SPINE INTERBODY FUSION DEVICE | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009129735 | 3009129735 | CUTTING EDGE SPINE | 6012 Waxhaw Highway, Mineral Spgs, NC 28108 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
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