PT SOLUTIONS, LLC

FDA Device Registration & Listing · Brunswick, OH, US · Registration 3014967552

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
3014967552
FEI Number
3014967552
Entity Name
PT SOLUTIONS, LLC
City/State/Country
Brunswick, OH, US
Establishment Address
2985 Nationwide Parkway, Brunswick, OH 44212, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PT Solutions, LLC (Owner Number: 10058303)
Owner / Operator Contact Address
2985 Nationwide Pkwy, Brunswick, OH 44212, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PTS Distraction Screw PRADO™ C HA PRADO™ Lumbar Interbody Fusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYQ Accessories, Fixation, Spinal Intervertebral Body Orthopedic Class 1 888.4540 2024-08-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-08-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PT Solutions, LLC
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
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014967552. Last updated year: 2026. Please use registration number 3014967552 when referencing this establishment in official correspondence.
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