FDA Registration
Active
🇮🇸 Iceland
Icelock® 772 Male Pyramid TI
Reg #: 3003764610
·
FEI: 3003764610
·
Expires 2025
Products
1
Proprietary Names
214
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- OSSUR H/F
- Registration Number
- 3003764610
- FEI Number
- 3003764610
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- GRJOTHALS 1-5
- City
- REYKJAVIK
- Country
- IS
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
US Agent
- Business Name
- Ossur
- Contact Name
- Katla Axelsdottir
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3823833
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2006-07-13 |
Proprietary Names
Icelock® 772 Male Pyramid TI
Female Insert For Prong LP TI Junior
Female Pylon Kit 100kg
Flex-Run Junior
Icelock® 544 Expulsion Plate
Icelock® 675 4-Hole Adapter TI
Male Single Adapter AL
4-Hole Tube Clamp AL
Cheetah Xplore
Icelock® 234 Lanyard
Icelock® 562 Hybrid Unity DS
Threaded Female Pyramid Adapter TI
Unity for Pro-Flex LP
4-Hole Socket Adapter Junior
Cheetah Xcel
Foot cover FSM
Icelock® 214 4-Hole Clutch
Icelock® 562 Hybrid Passive Vacuum DS
Talux
Velocity Adapters
3-Prong Socket Adapter SS
Flex-Foot Assure
Male Double Adapter AL
Female Pylon Kit 166 kg
Vacu Valve
Flex-Symes
Icelock® 721 Ratchet
4-Hole Male Pyramid Adapter Junior
Male Single Adapter TI
Foot cover FCT
Male Tube Clamp TI
4-Hole Female Pyramid Adapter Rotation TI
4-Prong Socket Adapter Junior
Icelock 400 Standard Lamination
Icelock® 544 LL Kit
Pro-Flex Pivot
Velocity Kits
4-Hole Female Pyramid Adapter Rotation SS
4-Prong Socket Adapter SS
Flex-Run
Icelock 214 Clutch AK Offset
Icelock® 544 Expulsion Valve Kit
Pro-Flex Modular
Velocity Plates
4-Hole Male Pyramid Adapter TI
Foot cover FSF
Icelock® 125 Ratchet Fabrication Kit Without Braid
Nike SoleX Attachment Kit
SACH Foot Adapter Junior
Shin Foam
4-Hole Female Pyramid Adapter AL
Flex-Foot Cheetah®
Height Adjustable Pylon
Male Insert For Prong Junior
Cheetah Xceed
Pro-Flex LP Align
Female Insert For Prong TI
Icelock® 544 EP Kit
Icelock® 672 Male Pyramid TI
Unity for Flex-Foot Assure & Balance Foot J
Single Density Shin Fairing Block
Vari-Flex Modular
Female Pylon AL
Icelock® 544 EP Plate
Icelock® 673 Male Pyramid AL
Unity for LP Vari-Flex
4-Hole Male Pyramid Adapter 8mm Offset TI
Balance Foot J
Icelock 600 Series Spacer For Direct Socket
Icelock® 331 Thermoplastic Sockets
Icelock® 544 Reservoir Kit
4-Hole Male Pyramid Adapter Rotation SS
Pro-Flex XC Torsion
Tube
Foot cover FJS
Male-Female Double Adapter With Offset SS
Re-Flex Shock
Female Pylon TI WP
Foot cover FCLA
Icelock® 721 Ratchet Pin Adapter
Male Socket Adapter TI
4-Hole Male Pyramid Adapter Rotation TI
Foot cover FSE
Icelock® 125 Ratchet Fabrication Kit With Braid
Nike Sole
SACH Foot Adapter AL
Pro-Flex ST
Black Spectra Socks
Female Insert For Prong Junior
Icelock® 125 Ratchet
Icelock® 400 Single Lamination with 4-hole Adapter
Icelock® 544 Unity Plate
Icelock® 641 Valve Adaption Kit
Unity for Balance Foot S
4-Hole Socket Adapter TI
Cheetah Xpanse
Icelock® 214 Clutch DS
Icelock® 562 Hybrid Unity Connector
Threaded 4-Hole Socket Adapter AL
4-Hole Socket Adapter AL
Foot Cover FSL
Icelock® 211 Clutch
Icelock® 562 Hybrid Passive Vacuum
Nike Spike Pad
SACH Foot Adapter TI
Dual Density Shin Fairing
4-Hole Female Pyramid Adapter TI
Aspire Foot
Icelock 562 Hybrid
Icelock® 544 LL Plate
Pro-Flex XC
Torsion Shock Adapter
Cheetah Xtend
Icelock® 272 Male Pyramid TI
Icelock® 600XM Ratchet
Threaded Male Pyramid Adapter SS
Unity for Proprio Foot
4-Hole Male Pyramid Adapter AL
Female Single Adapter AL
Foot cover FCPE
Male Tube Clamp AL
Female Double Adapter TI
Female Tube Clamp Junior
Icelock® 631 Lanyard Adaption Kit
Knee Rotation Adapter
Unity® Valve TF
Female Double Adapter AL
Female Tube Clamp AL
Icelock® 631 Lanyard
K2 Sensation® with D/P Flexion
Unity Valve
Female Pylon AL TI
Icelock® 544 Expulsion Kit
Icelock® 674 4-Hole Adapter AL
Male Pyramid Adapter
Unity for Pro-Flex
Balance Foot S
Icelock 600 XM Male Pyramid
Icelock® 400 BOA-System Lamination
Icelock® 544 Reservoir Plate
Proprio Foot
Tube Junior
4-Hole Female Pyramid Adapter Junior
Flex-Foot Junior
Height Adjustable Pylon - Junior
Icelock® 544 Expulsion Valve
Male Insert For Prong TI
Pro-Flex LP Torsion
4-Hole Tube Clamp TI
Cheetah Xplore Junior
Icelock® 234 Lanyard Adaptation Kit
Icelock® 600 XM Socket Adapter
Threaded Male Pyramid Adapter Junior
Unity for Pro-Flex XC
4-Hole Female Pyramid Adapter 20/20 Offset AL
Flex-Foot® Balance with D/P Flexion
Foot cover FST
Male Insert For Prong
Pro-Flex LP
Female Double Adapter with Shift TI
Female Tube Clamp TI
LP Vari-Flex
Unity® Valve TT
Discontinuous cosmetic foam
Cheetah Xtreme
Icelock® 273 Male Pyramid SS
Icelock® 621 Ratchet
Icelock® 773 Male Pyramid AL
Threaded Male Pyramid Adapter TI
Unity for Vari-Flex
Continuous Cosmetic Foam
Calf cosmesis
Female Insert For Prong LP TI
Icelock® 544 E2 Connector
Icelock® 551 Expulsion Valve
Icelock® 651 Smooth
Unity for Balance Foot S Torsion
Chopart
Female Single Adapter TI
Icelock® 331 Lamination Sockets
Icelock® 621 Ratchet Adaption Kit
K2 Sensation
Unity Kit for TF
Cheetah Junior
Female Insert For Prong SS
Icelock® 544 E2 Connector Kit
Icelock® 552 Expulsion Valve TF
Icelock® 651 Smooth Adaption Kit
Unity for FF Balance & K2 Sensation
Vari-Flex Junior
Balance Foot S Torsion
Icelock 774 4-Hole Adapter AL
Icelock® 400 Single / Double Lamination
Icelock® 544 Unity Kit
Icelock® 641 Valve
Re-Flex Rotate
Unity
4-Hole Connection Plate
Flex-Foot Balance
Male Double Adapter TI
Nike Spike SoleX
Vari-Flex
Ratchet Lock Body
Pro-Flex Terra
Icelock® 850 Hybrid for Laminated Sockets
Icelock® 850 Hybrid for Direct Socket
Adult male to junior female double adapter
SandalFix
Female Single Adapter Junior
Icelock® 850 Hybrid for 4-Hole Sockets
Pro-Flex LP Junior
Flexion Plate
FSW Foot Cover
Female Single Adapter 5mm Offset Junior
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device