FDA Registration Active 🇩🇪 Germany

Footshell Runway Regular

Reg #: 9616494 · FEI: 3003117657 · Expires 2025
Products
1
Proprietary Names
128
Establishment Types
4
Classifications
1

Registration Details

Registration Name
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
Registration Number
9616494
FEI Number
3003117657
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Max-Naeder-Strasse 15
City
DUDERSTADT Lower Saxony
Country
DE

Owner / Operator

Firm Name
Ottobock SE & Co. KGaA
Operator Number
8010097
Address
Max-Naeder-Strasse 15
City
Duderstadt
State
Lower Saxony
Postal Code
37115
Country
DE

US Agent

Business Name
Otto Bock HealthCare LP
Contact Name
Caleb Beck
Address
3820 West Great Lakes Drive
City
Salt Lake City
State
UT
ZIP
84120
Country
US
Phone
801 9746647

Products

Device Name Product Code
Component, External, Limb, Ankle/Foot ISH

Proprietary Names

Footshell Runway Regular Bionic-Foot Footshell Sliding Plate hole plate Taleo LP Symes Taleo VS, Taleo Harmony Freestyle Swim Foot for water resistant prothesis Tube-Adap,Short-34mm Steel Tube Adapter f. water resist. Prothesis Slide Adap. With 4 Screw Conn Footshell Runway HX Regular Greissinger plus foot Connection Cap for 2C1 small Sliding Adapter Connection Cap Modular Transtibial Kit Axtion DP ProSymes Prosthetic Foot Single Axis Foot Adapter Tube Adaptor, long, Aluminum Trias Single Axis Foot Only Men Tube Adaptor,Long,Titan Sole Kit 1E90 Sprinter - with Spikes Sprinter Dynamic foot with toes SACH Foot Bk Kit-34mm-Clamp-Steel Tube Adapter, short, 34 mm, Titanium Sliding Adaptor -Titanium- Taleo Side Flex Cosmetic Light Foot with Toes Tube Adaptor,Short,Titan Double Adaptor w. Screws Footshell Runway Sandal Runner Footshell 1C40 Foot Adapter-Titan- Slide Clamp-Alum Socket Att.Block Mod.F.Ch Runway HX Spherical Sliding Adapter DeltaTwist Promenade Terion Shaped Ankle Block Connection Adapter Triton SACH Foot,Child Tube-Adapter, Children Lo Rider C-Walk SACH plus Foot Tube Adaptor Aluminium Short Chopart Triton Side Flex SACH Foot,Child,Medium Bk Kit-34mm-Clamp-Titanium Foot Adapter Double Adapter with Pyramid Triton LP Maverick VS Anprobe-Sportadapter TT Challenger Foot Shell Gen2 Dynamic Ft,Women,20mm,Toes SACH-foot Tube Adapter, long, 34 mm, Titanium Taleo Footshell Foot Shell Gen3 Tube-Adap,Long-34mm-Steel Sliding Adapter -Titanium- ProCarve Foot Standard Tube-Adapter, long Trias Footshell Otto Bock Dynamic Foot for children Foot Adapter with thread Runner Sole Renegade AT Sole Kit 1E90 Sprinter Modular Transfemoral Kit Axtion Terion K2 Tube-Adapter, short Evanto Footshell Maverick Xtreme AT Footshell for 1M10 Tube Clamp Adaptor, SS Renegade LP-AT Kintrol TF Sports Foot Adapter Footshell for 1C10 Tube Adaptor, Angled, Titan 10 -20 -30 degrees Foots Shell Freestyle Swim Complete bolt assembly Evanto Taleo Adjust Meridium Footshell Gen2 High Foot Shell Kintrol TF Test-Sportfootadapter Tube Clamp Adaptor, Titan Restore Footshell-Child Definitiv-Sportadapter TT Footshell Runway HX Sandal Triton Vertical Shock Adjust Tube Adapter, angled, Children Defender Runway Tube Adaptor, angular 10 degrees, 20 degrees, 30 degrees, Titanium Runner junior Pyramid Adapter, rotatable Taleo LP Runner junior Single Axis Adapter Tube Clamp Adaptor-Alum. Dynamic Plus Prosthetic Foot Dynamic Motion Prosthetic Foot Footshell ProSymes Triton Harmony Maverick Comfort AT Pirogoff Foot Triton HD Maverick Footshell Sprinter Junior Maverick Junior Footshell Maverick Junior

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device