Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009404219

FEI Number

3009404219

Entity Name

THOMPSON MIS

City/State/Country

Sandown, NH, US

Establishment Address

17 Bobcat Way, Unit 7, Sandown, NH 03873, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Thompson MIS (Owner Number: 10038982)

Owner / Operator Contact Address

17 Bobcat Way, Unit 7, Sandown, NH 03873, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111512

PMA Number

N/A

All Registered Proprietary Names

BoneBac TLIF Mallet Nautilus One Step Dilator BoneBac TLIF Surgical Instrument Thompson MIS BoneBac TPLIF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2011-11-30
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-03-30
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2011-11-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2011-11-30

Official Correspondent

Mike Drnek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thompson MIS

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
1926681	JEDMED Instrument Company	Saint Louis, MO, US
3019878714	Alphatec Spine, Inc.	Memphis, TN, US
3004513872	FIVE STAR MANUFACTURING, INC.	NEW BEDFORD, MA, US
3012358417	Arthrocare Corporation	Coyol Alajuela, CR
3027262786	SOLENDOS., INC.	GURO-GU Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009404219. Last updated year: 2026. Please use registration number 3009404219 when referencing this establishment in official correspondence.