Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014273501

FEI Number

3014273501

Entity Name

Tangible Solutions, Inc. DBA Marle Tangible, Inc.

City/State/Country

Fairborn, OH, US

Establishment Address

678 Yellow Springs Fairfield Rd, Fairborn, OH 45324, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tangible Solutions, Inc. dba Marle Tangible, Inc. (Owner Number: 10056940)

Owner / Operator Contact Address

678 Yellow Springs Fairfield Rd, Fairborn, OH 45324, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 ZSFab Cervical Interbody System 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-12-15
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2022-06-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-09-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-07-11
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2025-12-15
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-12-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-12-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-02-08
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2023-02-08
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-02-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-02-01
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2022-06-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-07-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-07-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-01-02
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-07-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-07-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-07-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-11-29
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-03-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-03-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-07-28
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-04-22
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2022-12-08
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-12-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-12-08
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2022-12-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-11-29
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2021-07-28

Official Correspondent

Kriss Anderson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tangible Solutions, Inc. dba Marle Tangible, Inc.

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number	Establishment Name	Location
3013843055	BEIJING AK MEDICAL CO, LTD	Changping District Beijing, CN
3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
8043862	AAP IMPLANTATE AG	BERLIN, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014273501. Last updated year: 2026. Please use registration number 3014273501 when referencing this establishment in official correspondence.