FDA Registration
Active
🇺🇸 United States
SPINAL SIMPLICITY, LLC
Reg #: 3009704301
·
FEI: 3009704301
·
Expires 2026
Products
10
Proprietary Names
18
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- SPINAL SIMPLICITY, LLC
- Registration Number
- 3009704301
- FEI Number
- 3009704301
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6363 College Blvd, Suite 320
- City
- Overland Park
- State
- KS
- ZIP
- 66211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231923
Owner / Operator
- Firm Name
- Spinal Simplicity, LLC
- Operator Number
- 10041761
- Address
- 6363 College Blvd, Suite 320
- City
- Overland Park
- State
- KS
- Postal Code
- 66211
- Country
- US
- Correspondent
- Adam Rogers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-12-20 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2026-04-29 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-04-29 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2018-07-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-12-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-11-03 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-06-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-12-06 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2023-12-06 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-08-29 |
Proprietary Names
Liberty SI Lateral Implant System
Freedom DS Decompression System
G1 Minuteman
Minuteman G5 Mis Fusion Plate; Minuteman G1(Posterior Fusion Plate /Ha Posterior Fusion Plate); Ha Minuteman G3-R Mis Fu
Minuteman G5
Minuteman G6 MIS Fusion Plate
Instrument Surgical Tray
Patriot SI Surgical Instruments
Liberty SI Surgical Instruments
Minuteman Surgical Instruments
Wolff's Law Anterior Cervical Plate System
Minuteman G1
Minuteman G3
Edge Upper Cervical System
G-2 Inserter
Patriot-SI Posterior Implant System
HA Minuteman G3-R MIS Fusion Plate
HA Minuteman G3 MIS Fusion Plate
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Device in the United States for Export Only
Manufacture Medical Device