FDA Registration
Active
🇺🇸 United States
Tangible Solutions, Inc. DBA Marle Tangible, Inc.
Reg #: 3014273501
·
FEI: 3014273501
·
Expires 2026
Products
12
Proprietary Names
28
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Tangible Solutions, Inc. DBA Marle Tangible, Inc.
- Registration Number
- 3014273501
- FEI Number
- 3014273501
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 678 Yellow Springs Fairfield Rd
- City
- Fairborn
- State
- OH
- ZIP
- 45324
- Country
- US
Owner / Operator
- Firm Name
- Tangible Solutions, Inc. dba Marle Tangible, Inc.
- Operator Number
- 10056940
- Address
- 678 Yellow Springs Fairfield Rd
- City
- Fairborn
- State
- OH
- Postal Code
- 45324
- Country
- US
- Correspondent
- Kriss Anderson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-12-15 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-06-27 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-09-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-07-11 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2025-12-15 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-12-08 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-02-08 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2023-02-08 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-02-08 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2022-06-13 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2021-07-28 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2018-11-29 |
Proprietary Names
Intraosseous Fusion Device System
T-FIX® 3DSI Joint Fusion System
ZSFab Cervical Interbody System
Edge Upper Cervical System
Auxano Wedge Fixation System
IO Freedom
EVOLUTION SPINE Interbody System
Kleiner KG2 System
Better Bunion System
CALYPSO 3DR LLIF
CALLISTO 3DR PLIF
ANTARES 3DR ALIF
HYPERION 3DR TLIF
Tailored-C
Intervertebral fusion device with bone graft, lumbar
Intervertebral fusion device with integrated fixation, cervical
Genesys Spine 3DP Cervical Interbody System
RIGEL 3DR Cervical Interbody System
WaveForm A Interbody System
SPIRA-P
SPIRA-T
Patriot-SI Posterior Implant System
Pisces-SA Standalone ALIF Interbody System
Aries Lumbar Interbody System
Genesys Spine Sacroiliac Joint Fusion System
SPIRA-C Integrated Fixation System
Genesys Spine 3DP Lumbar Interbody System
ZSFab Lumbar Interbody System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)