EMPIRICAL SPINE, INC.

FDA Device Registration & Listing · Morgan Hill, CA, US · Registration 3013114075

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
3013114075
FEI Number
3013114075
Entity Name
EMPIRICAL SPINE, INC.
City/State/Country
Morgan Hill, CA, US
Establishment Address
18655 Madrone Pkwy Ste 180, Morgan Hill, CA 95037, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Empirical Spine, Inc. (Owner Number: 10095318)
Owner / Operator Contact Address
18655 Madrone Pkwy., Suite 180, Morgan Hill, CA 95037, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P220031

All Registered Proprietary Names

Limiflex Dynamic Sagittal Tether Symbol Plate Limiflex Dynamic Sagittal Tether Instrument Tray Limiflex Dynamic Sagittal Tether Holder Limiflex Dynamic Sagittal Tether Tensioner Limiflex Dynamic Sagittal Tether Passer Limiflex Dynamic Sagittal Tether Limiflex Dynamic Sagittal Tether Driver Limiflex Dynamic Sagittal Tether Tensioner Clip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SGK Prosthesis, Spinous Process Tension Band Implant Unknown Class 3 N/A 2026-02-25

Official Correspondent

Louie Fielding

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Empirical Spine, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3031365458 WOMED SAS Montpellier Herault, FR
3009999323 STORE-ALL LOGISTICS LTD Slieverue Kilkenny, IE
3008478369 FERROSAN MEDICAL DEVICES A/S Soeborg Hovedstaden, DK
3028907862 XVIVO PERFUSION, INC. Aurora, CO, US
3009969279 Medifocus Inc Columbia, MD, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013114075. Last updated year: 2026. Please use registration number 3013114075 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.