Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017697442

FEI Number

3017697442

Entity Name

Spinal Systems, LLC

City/State/Country

Louisville, KY, US

Establishment Address

8075 National Turnpike, Louisville, KY 40214, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Spinal Technology, LLC (Owner Number: 9039913)

Owner / Operator Contact Address

191 Mid Tech Drive, --, West Yarmouth, MA 02673, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Custom Transfemoral Check Socket Custom Transfemoral Definitive Socket Custom Transtibial Definitive Socket Custom Symes Check Socket Custom Symes Definitive Socket Custom Transtibial Check Socket Scoliosis/Kyphosis Orthosis Flex Foam 1 Low Profile with Custom Sternal Shield S.T.O.P. 1 TLSO Milwaukee Orthosis Full-Time Scoliosis Orthosis S.T.O.P. 4 Hip Orthosis Flex Foam 2 S.T.O.P. 3 S.T.O.P. 2 Flex Foam 3 Providence Nocturnal Scoliosis Orthosis SpinaLoc 2 stWear® Portal stWear® Smartphone App Providence Nocturnal Scoliosis Orthosis Full-Time Scoliosis Orthosis Pectus Brace CTLSO Flex Foam 1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	Class 1	890.3420	2025-11-18
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2019-12-11
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2025-11-18
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2019-12-11
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2019-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spinal Technology, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1226318	SPINAL TECHNOLOGY, LLC	West Yarmouth, MA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017697442. Last updated year: 2026. Please use registration number 3017697442 when referencing this establishment in official correspondence.