Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011219098

FEI Number

3011219098

Entity Name

MFG AMP

City/State/Country

Tijuana Baja California, MX

Establishment Address

Blvd. Heroes de la Independencia No. 25420, Colonia Fideicomiso El Florido, Tijuana Baja California 22245, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ASPEN MEDICAL PRODUCTS, LLC (Owner Number: 9027491)

Owner / Operator Contact Address

6481 OAK CANYON, --, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Comfortrac DuAlign OA Aspen OA Knee Wrap Aspen OA Knee+ CROSS-FIT MIN-KNEE Paladin XT WRAP-AROUND VISTA COLLAR VISTA MULTIPOST THERAPY COLLAR VRTX COLLAR VRTX TX COLLAR VRTX MULTI POST COLLAR SIERRA COLLAR ASPEN COLLAR VISTA TX COLLAR ASPEN PEDIATRIC COLLAR Silicone Elastic Elastic Slip-On Active Compression Universal OA Forte Unloader Knee Brace Velpeau Immobilizer Premium Wrist Brace Air Lite Tracer ROM Telescoping Post Op Elbow Brace Ankle Helper Deluxe Shoulder Abduction System Stabilizer Aspen Knee Suspension Wrap Aspen Hinged Knee Aspen Hinged Wrist Aspen ROM Knee Aspen Ci Knee Lace-Up Ankle Carpal Tunnel Wrist Brace Cock-up Elastic Wrist Brace Sport Lite Wrap-Around Thumb Spica Wrist Brace K.S. Lace-Up Quick Lace Neoprene Tennis Elbow Sleeve Sport Knee Gator Wrap Premium Thumb ROM Telescoping Post Op Knee Brace Panther Unloader Knee Brace Hinge ROM Elbow Neoprene Thigh Sleeve Min-Knee PFS Night Splint Cross-Fit Visco-Gel Silicone Air-Gel VerteShield Apex SUMMIT TLSO ASPEN CTO Sierra TLSO PEAK SCOLIOSIS BRACING SYSTEM CONTOUR TLSO HORIZON TLSO VISTA TLSO VISTA CTO ASPEN TLSO 457 ASPEN TLSO EVERGREEN TLSO ASPEN OTS 457 TLSO ASPEN SCOLIOSIS BRACING SYSTEM Aspen Active P-TLSO Aspen Acute TLSO Sierra Hyperextension TLSO Elite TLSO VRTX TLSO VISTA II CTLSO VRTX CTO ALIGN ORTHOSIS VRTX CTLSO FLX TLSO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2023-03-03
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2020-07-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	1996-08-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2020-09-02
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	1997-05-23

Official Correspondent

JAMES CLOAR

US Agent Details

JAMES CLOAR Business: ASPEN MEDICAL PRODUCTS, LLC Email: jhamilton@aspenmp.com Phone: (949) 6810200

Related Public Records

Same Entity

ASPEN MEDICAL PRODUCTS, 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
2530195	ADVANCED ORTHOPAEDICS, LLC	Bloomsburg, PA, US
2030775	ASPEN MEDICAL PRODUCTS, LLC	IRVINE, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011219098. Last updated year: 2026. Please use registration number 3011219098 when referencing this establishment in official correspondence.