Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021192165

FEI Number

3021192165

Entity Name

3Spine, Inc.

City/State/Country

Chattanooga, TN, US

Establishment Address

801 Broad Street, 6th Floor, Chattanooga, TN 37402, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

3Spine, Inc. (Owner Number: 10083637)

Owner / Operator Contact Address

801 Broad Street, 6th Floor, Chattanooga, TN 37402, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

General Instruments 3Spine System Set General Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-11-04
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-12-08
HWT	Template	Orthopedic	Class 1	888.4800	2022-10-11

Official Correspondent

Ron Yarbrough

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

3Spine, Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021192165. Last updated year: 2026. Please use registration number 3021192165 when referencing this establishment in official correspondence.