Ossur Mexico

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3008523132

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
3008523132
FEI Number
3008523132
Entity Name
Ossur Mexico
City/State/Country
Tijuana Baja California, MX
Establishment Address
Boulevard Hector Teran Teran 2102, Edificio #1, Col. Canon del Padre, Tijuana Baja California CP 22206, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
OSSUR Americas (Owner Number: 9026971)
Owner / Operator Contact Address
200 Spectrum Center Drive, Suite 700, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CTi Mission Oversleeve Neoprene FX Patella Stabilizer Ski boot attachment Unloader One® X Custom Formfit OA Ease Rebound® Cartilage Custom Flex MX Gear Guards CTi 3 Formfit Knee Hinged Lateral J Neo AMS Wrap OTS Rebound® ACL Premium Elastic Knee Support SportSleeve AMS Sleeve Formfit Knee Braces MX Patella Cup Rebound Post Op Knee Suspension Strap Kit AMS Wrap Silicone AMS Wrap Unloader One X Formfit Knee MCL Rebound® Cartilage Flexion Stop Kit Extreme Lycra Liner CTi3 PCL Strap Anti-Migration System (AMS) Wrap EVA Neoprene Knee Sleeve CTi OA Padded Sports Oversleeve AMS Wrap NEO - CTi® Custom Formfit Knee Immobilizer Neoprene Hinged Knee Support Rebound® ACL Custom Elastic Calf Suspension Strap Paradigm Custom SoftSleeve CTi Custom Non-elastic Thigh Strap Formfit Hinged Knees MX Kit Rebound Knee Immobilizer Universal CTi3 Impact Guard Thigh/Calf liner EVA Exoform Knee Immobilizer Patella cup Softsleeve C180 Rocket Neoprene Knee Support with Stabilized Patella Unloader Custom Condyle Pad Kit Neoprene Wraparound Hinged Knee Support Knee shield Formfit Pro Knee Rebound® PCL Custom Unloader One Plus Unloader Spirit Undersleeve Neoprene Undersleeve Formfit ROM Knees Formfit Pro Knee OA Unloader One Formfit Post-Op Knee Rebound® PCL Unloader One Custom Rebound Knee Strap and Pad Kit OA Ease Formfit Knee Buttress Extension Stop Kit OA Move PCL Kit for CTi® Miami TLSO 456 Miami TLSO 464 Formfit Night Splint Equalizer Pre-Inflated Air Walker Rebound Diabetic Walker Form Fit Equalizer Walker Low Top Formfit Walker Air Low Top Formfit Ankle with SpeedLace Pediatric Walker Formfit Ankle with Figure 8 Rebound Foot Up Formfit Ankle Formfit Walker Low Top Formfit® Walker Air Formfit Night Splint Posterior Formfit Walker DH OffLoading Walker Formfit Honeycomb Ankle Stirrup Adhesive Insole for wedge Durable Weather Cover Exoform Dorsal Night Splint Formfit Pro Ankle AirForm Pre-inflated Ankle Stirrup Formfit Ankle Stirrup Foam Wedge Formfit Air Ankle Stirrup Rebound Air Walker AirForm Night Splint Foot Up Achilles heel wedge Formfit Gel Ankle Stirrup Hygiene Cover Metal Strut Air Walker Disposable Weather Cover Width Extender kit Strap Extension AFO Light Equalizer Pre-Inflated Air Walker Low Top Equalizer Air Walker Low Top Equalizer Air Walker Rebound Ankle Brace Equalizer Walker Rebound Air Walker LT AFO Leaf Spring AFO Dynamic GameDay Lace Up Equalizer Walker Low Top Rebound Dual Rebound Dual ST Formfit Pro Knee Flite Formfit Tracker Rebound Dual Recover Rebound Dual Basic Rebound DUAL Custom Rebound Dual Basic ST Rebound DUAL ST Custom NEURO SWING AFO 4-Hole adapter Double Adapter Double Pyramid Receiver Icelock® 700 Adapters Double Pyramid Adapter Pylon Kit SACH Foot Adapter Height adjustable pylon Threaded Adapter Foot cover FCT Icelock® 721 Ratchet Pin Adapter Pro-Flex Modular Icelock® 562 Hybrid Unity Connector K2 Sensation Vari-Flex Modular Cheetah Xplore Icelock® 544 Expulsion Valve Unity for Pro-Flex Velocity Plates Icelock® 125 Ratchet Icelock® 544 EP Kit Pro-Flex LP Unity for Balance Foot S Torsion Velocity Adapters Foot cover FSM Icelock® 621 Ratchet LP Vari-Flex Icelock 214 Clutch AK Offset Nike SoleX Attachment Kit Torsion Shock Adapter Pro-Flex ST Foot Cover FSL Icelock® 331 Lamination Sockets Proprio Foot Unity for Proprio Foot Height Adjustable Pylon Nike Sole Balance Foot J Icelock® 400 BOA-System Lamination Re-Flex Shock Unity Kit for TF Chopart Icelock® 544 Reservoir Kit Icelock® 631 Lanyard Adaption Kit Cheetah Xpanse Icelock® 214 4-Hole Clutch Icelock® 544 Expulsion Plate Unity for LP Vari-Flex Continuous Cosmetic Foam Cheetah Xtend Icelock® 544 LL Kit Icelock 562 Hybrid Unity Nike SoleX Icelock® 621 Ratchet Adaption Kit Unity for Pro-Flex XC Unity for Balance Foot S Dual Density Shin Fairing Icelock® 600XM Ratchet Knee Rotation Adapter Flex-Foot Balance Flex-Foot Junior Icelock® 641 Valve Adaption Kit Flex-Foot Assure Flex-Foot Cheetah® Icelock® 544 Reservoir Plate Icelock® 641 Valve Foot cover FJS Icelock® 214 Clutch DS Icelock® 773 Male Pyramid AL Pro-Flex Pivot Icelock 400 Standard Lamination Nike Spike Pad Unity Shin Foam Foot cover FSE Icelock® 234 Lanyard Pro-Flex XC Foot cover FST Male Pyramid Adapter Flex-Symes Icelock® 721 Ratchet Pro-Flex LP Torsion Balance Foot S Foot cover FSF Icelock® 400 Single / Double Lamination Icelock® 544 Unity Kit Icelock® 234 Lanyard Adaptation Kit Pro-Flex XC Torsion Talux Unity Valve Flex-Foot® Balance with D/P Flexion Flex-Run Icelock® 651 Smooth Calf cosmesis Icelock® 544 E2 Connector Kit Icelock® 552 Expulsion Valve TF Vacu Valve Flex-Run Junior Icelock® 651 Smooth Adaption Kit Pro-Flex LP Align Icelock® 562 Hybrid Unity DS K2 Sensation® with D/P Flexion Cheetah Xcel Icelock® 211 Clutch Icelock® 544 Expulsion Kit Unity for Flex-Foot Assure & Balance Foot J Single Density Shin Fairing Block Cheetah Xtreme Icelock® 544 LL Plate Icelock® 631 Lanyard Cheetah Xplore Junior Icelock® 544 Expulsion Valve Kit Unity for Pro-Flex LP Velocity Kits Black Spectra Socks Icelock® 544 E2 Connector Icelock® 551 Expulsion Valve Unity® Valve TT Balance Foot S Torsion Icelock® 400 Single Lamination with 4-hole Adapter Icelock® 544 Unity Plate Unity® Valve TF Cheetah Xceed Icelock® 562 Hybrid Passive Vacuum DS Vari-Flex Junior Cheetah Junior Icelock® 562 Hybrid Passive Vacuum Vari-Flex Icelock® 125 Ratchet Fabrication Kit Without Braid Icelock® 544 EP Plate Unity for FF Balance & K2 Sensation Discontinuous cosmetic foam Aspire Foot Icelock® 331 Thermoplastic Sockets Re-Flex Rotate Unity for Vari-Flex Pro-Flex Terra Flexion Plate SandalFix FSW Foot Cover Ratchet Lock Body Pro-Flex LP Junior Icelock® 600 Adapters Icelock® 850 Hybrid for Laminated Sockets Icelock® 850 Hybrid for Direct Socket Icelock® 200 Adapters Shift Adapter Insert for Prong Pronged adapter Single Adapter Icelock® 850 Hybrid for 4-Hole Sockets Pylon Tube Clamp Socket Adapter Livingskin Partial finger Livingskin Toe Livingskin Full hand Livingskin Finger band Livingskin Below elbow Livingskin Partial hand Livingskin Foot Livingskin Full finger Livingskin Above Elbow Livingskin PIPDriver® MCPDriver® ThumbDriver® GripLock Finger® Hot/Cold Therapy Gel Pad

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 1993-01-01
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2010-03-15
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2002-07-06
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2006-10-18
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 2006-07-13
IRA Hand, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2004-01-07
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2002-07-06

Official Correspondent

No official correspondent registered.

US Agent Details

Katla Axelsdottir Business: Ossur Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

OSSUR Americas
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008395545 OSSUR Newburgh, NY, US
3010405373 Ossur Orlando Orlando, FL, US
3003764610 Ossur Iceland ehf. REYKJAVIK, IS
3004161950 OSSUR EUROPE B.V. Eindhoven Noord-Brabant, NL
3006532285 Touch Bionics Ltd Livingston West Lothian, GB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008523132. Last updated year: 2026. Please use registration number 3008523132 when referencing this establishment in official correspondence.
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