Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226318

FEI Number

3002855566

Entity Name

SPINAL TECHNOLOGY, LLC

City/State/Country

West Yarmouth, MA, US

Establishment Address

191 MID TECH DR., West Yarmouth, MA 02673, 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

Providence Nocturnal Scoliosis Orthosis Full-Time Scoliosis Orthosis Pectus Brace stWear® Compliance Monitor LSO Full-Time Scoliosis Orthosis SpinaLoc Flex Foam 1 Flex Foam 3 Flex Foam 2 Providence Nocturnal Scoliosis Orthosis CTLSO Flex Foam 1 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2019-12-11
NHF	Monitor, Orthotic/Prosthetic	Physical Medicine	Class 1	890.3025	2025-11-18
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2019-12-11
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2019-12-11
MRI	Orthosis, Truncal/Orthosis, Limb	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
3017697442	Spinal Systems, LLC	Louisville, KY, US

Similar Registrations

Registration Number	Establishment Name	Location
3010884328	SCOLICARE	Kogarah New South Wales, AU
3009562727	Eckart KLOBE	Mannheim Baden-Wurttemberg, DE
3016426850	COFOE MEDICAL TECHNOLOGY CO.,LTD	Changsha Hunan, CN
3012453117	TREND MEDICAL, LLC	Bethlehem, PA, US
3010694026	BREG, INC.	Indianapolis, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226318. Last updated year: 2026. Please use registration number 1226318 when referencing this establishment in official correspondence.