FDA Registration
Active
🇺🇸 United States
Ossur Orlando
Reg #: 3010405373
·
FEI: 3010405373
·
Expires 2026
Products
3
Proprietary Names
235
Establishment Types
2
Classifications
3
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Registration Details
- Registration Name
- Ossur Orlando
- Registration Number
- 3010405373
- FEI Number
- 3010405373
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9545 S John Young Pkwy, Suite 100
- City
- Orlando
- State
- FL
- ZIP
- 32819
- Country
- US
Owner / Operator
- Firm Name
- OSSUR Americas
- Operator Number
- 9026971
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2006-10-18 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2006-07-13 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2002-07-06 |
Proprietary Names
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
Aerofit® Vents
Iceross Direct Casting Liner
Aspire Locking
Iceross Dermo Cushion
Iceross Comfort Locking
Iceross Seal-In X
Ossur Brim
Iceross Seal-In X5
Iceross Sleeve
Iceross Socks
First
Direct Socket Tool Kit
Iceross Dermo Locking
Relax Cushion
Iceflex Balance Sleeve
AKOS
Iceross Curvemaster
Iceross Sport Locking
Iceross Dermo Uniform Cushion
Iceross Seal-In X seals
Iceross Seal-In X TF
Protect Cushion
Iceross Interface Sheath
Soft C
Iceross Distal Cup
Sensitive Locking
Iceross Seal-In X5 TF
Iceross Post-Op TF
Iceform Sleeve
Iceross Stabilo Junior Locking
Iceross Seal-In X Locking
Protect Locking
Iceross Original Locking
4Seal Classic
Iceross Dermo Uniform Locking
Iceross Post-Op TT
Iceross Transfemoral Locking
Iceross Dermo Seal-In
Relax Locking
Iceform Locking Liner
Iceross Synergy Locking
Connect TF
Iceross Dermo Junior Locking
Relax Transfemoral
Iceform Cushion Liner
Iceross Synergy Cushion
Iceross Activa Cushion
Iceross Seal-In Transfemoral
Iceross Upper-X Locking
Iceross Comfort Cushion
Iceross Seal-In V
Iceross Pads
Genu Sleeve
Aspire TF Locking
Definitive Socket TF
Check Socket TT
Protector Sleeve
4Seal Senso
Iceross Seal-In Socks
Pressure Pads
Knee Lanyard kit for Connect TF
Check Socket TF
AeroFit Seal-In
Definitive Socket TT
IcePro Socket TF Diagnostic
Direct Socket
IcePro Socket TT Diagnostic
AeroFit Socket
IcePro Socket TT
IcePro Socket TF
Iceross Seal-In X Locking TF
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)