Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021520203

FEI Number

3021520203

Entity Name

Mainstay Medical (MML US, Inc.)

City/State/Country

San Diego, CA, US

Establishment Address

2159 India Street, San Diego, CA 92101, US

Establishment Type(s)

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

Owner / Operator

Mainstay Medical Limited (Owner Number: 10076126)

Owner / Operator Contact Address

2159 India St, San Diego, CA 92101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ReActiv8 ReActiv8 Release Tool

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLK	Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2020-07-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-01-19

Official Correspondent

Sheila Bruschi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mainstay Medical Limited

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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
1035166	OSCOR INC.	PALM HARBOR, FL, US
3018033084	NEXT GENERATION TOOLING INC	Akron, OH, US
3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021520203. Last updated year: 2026. Please use registration number 3021520203 when referencing this establishment in official correspondence.