Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1721652

FEI Number

1721652

Entity Name

OTTO BOCK HEALTHCARE LP

City/State/Country

Salt Lake City, UT, US

Establishment Address

3820 West Great Lakes Drive, Salt Lake City, UT 84120, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ottobock SE & Co. KGaA (Owner Number: 8010097)

Owner / Operator Contact Address

Max-Naeder-Strasse 15, Duderstadt, DE-NI 37115, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213587

PMA Number

N/A

All Registered Proprietary Names

CTO Cervicle Thoracic Orthosis Socket Adapter - titanium - B.K. Socket Adapter-Titanium Socket Adaptor w. Adjustment Screws Klima-Arm Liner Knee Cap, reinforced Derma Seal forte Varos Liner Eingussanker, gew. Arm, JK Socket Adaptor with Rotation Pyramid Lamination Anchor Sock.Adpt. , Adjust.Screws Derma Seal Gel Socks Rotatable Sock.Adapt.Titan Lamination Ring up to 150 kg Socket Adapter - aluminium - Two-Directional Rubber Knee Cap Sock.Adapt.With Pyramid Titan Socket attachment block for thermoplast socket Sock.Adapt.With Adjust.Screws ProSeal Ring Socket Adapter w. Pyramid Socket Attachment Block Socket Adapt.with Pyramid Dynamic Vacuum System System-Extension Assist Socket Adaptor-Aluminum MagnoFlex Lock Shuttle Lock Double Adapter Rotatable 4 prong Adapter with adj screws Varos Lamination Anchor with angled arm Socket Adapter w. Rotation Adjustment lam. Anchor f. water resist. Prothesis Rotatable 4 prong Adapter with Pyramid Socket Adaptor-Child Socket Adapter Tube Clamp Adaptor Rotatable Socket Adaptor Dorso Osteo Care Spinal Orthosis Lumbo Direxa Stable Lumbo Sensa, women Spine Sport Dosi EQ X Multi 627, 631, 637 Lumbo Sensa Lumbo Direxa Woman Dorso Direxa Posture Dorso Carezza Posture Lumbo Carezza Lumbo Direxa High Dyneva Dorso Direxa Basic Dyneva light Hyperextension orthosis Hyperextension brace Lumbo Tristep Lumbo Direxa Wristoform wrist support Hallux Valgus ComfortT Manu 3D Correction adapter set C-Brace Trial Orthosis Foot Plates ORTHOVALLEY AFO Solid Ankle Ankle Joint -Stainl.Steel- Manu 3D Basis Stainless Steel Elbow Joint Bars Acro ComforT Shoulder Support Epi Forsa Plus Epi Sensa Ankle Foot Orthosis ORTHOVALLEY AFO Night Splint ORTHOVALLEY AFO articulated Malleo Immobil Air Walker, low Hallux Valgus Combo ComfortT Manu Comfort Ankle Joint for Children Manu 3D Pollex Stainless Steel Elbow Joint Bar with Gable Lock Manu Comfort Stable Double Act. Ankle Jt. Child Epiflex Stainless Steel Elbow Joint Bar without Lock ORTHOVALLEY Supramalleolar Orthosis Syst. Positioning Joint Thumboform Long Malleo Immobil Air Walker, high Omo Neurexa Plus MyCRO Band Passport LSO Smartspine LSO Standard Ottobock Fulcrum LSO Low Profile LSO Lite MAC Standard Comprehensive LSO Smartspine LSO Low Original 10 inch Standard Option 1, Option 2, Option 3 Low Profile LSO Pathway LS Smartspine TLSO Premium Plus Low-Profile Cybertech S.P.I.N.E. Brace Original Cybertech Low Pro 8 inch Cyber 8 inch Low-Profile LSO Dosi EQ X High SI Belt Low-Profile Empower Tube-Adap,Short-34mm Steel Definitiv-Sportadapter TT Sliding Adapter ProCarve Foot Standard Tube-Adapter, Children Double Adaptor w. Screws Sprinter Terion K2 Adjust Taleo Side Flex Renegade AT Foot for water resistant prothesis Tube-Adap,Long-34mm-Steel Meridium Runner Footshell for 1M10 Foot Adapter-Titan- Anprobe-Sportadapter TT Kintrol Bionic-Foot Footshell Sliding Adapter -Titanium- Maverick VS Connection Cap Trias Footshell Footshell Gen2 High Tube Adapter, long, 34 mm, Titanium TF Test-Sportfootadapter Sliding Plate hole plate Dynamic Plus Prosthetic Foot Dynamic Motion Prosthetic Foot Tube-Adapter, short Tube Adaptor Aluminium Short Shaped Ankle Block Tube Adaptor, long, Aluminum Spherical Sliding Adapter Runway HX Triton Side Flex Tube Adaptor, angular 10 degrees, 20 degrees, 30 degrees, Titanium Runway C-Walk Sprinter Junior Defender Foot Adapter with thread Tube Clamp Adaptor-Alum. Terion SACH Foot,Child Complete bolt assembly Axtion Triton Vertical Shock Cosmetic Light Foot with Toes Tube Adapter f. water resist. Prothesis DeltaTwist Runner junior Tube Adapter, angled, Children Connection Adapter Challenger Pirogoff Foot Lo Rider Triton LP Bk Kit-34mm-Clamp-Titanium Tube Adapter, short, 34 mm, Titanium TF Sports Foot Adapter Socket Att.Block Mod.F.Ch Dynamic Ft,Women,20mm,Toes Footshell 1C40 Runner Sole Maverick Comfort AT Maverick Junior Foot Shell Gen2 Single Axis Adapter Runner junior Pyramid Adapter, rotatable Foot Shell Kintrol Maverick Junior Footshell LP Symes Footshell Runway HX Sandal Tube Adaptor,Short,Titan Tube Clamp Adaptor, Titan Restore Single Axis Foot Only Men Tube Adaptor,Long,Titan Tube Adaptor, Angled, Titan 10 -20 -30 degrees Greissinger plus foot Otto Bock Dynamic Foot for children Evanto Bk Kit-34mm-Clamp-Steel Foot Shell Gen3 Footshell Runway Regular Single Axis Foot Adapter Foot Adapter Modular Transfemoral Kit Slide Clamp-Alum Footshell Runway Sandal Dynamic foot with toes Connection Cap for 2C1 small Slide Adap. With 4 Screw Conn Maverick Footshell ProSymes Prosthetic Foot Double Adapter with Pyramid Taleo SACH plus Foot Evanto Footshell Modular Transtibial Kit Freestyle Swim Footshell Runway HX Regular Footshell ProSymes Sole Kit 1E90 Sprinter - with Spikes Triton Maverick Xtreme AT Footshell-Child Tube-Adapter, long Tube Clamp Adapter Foots Shell Freestyle Swim Promenade Taleo Adjust Chopart Triton HD Footshell for 1C10 Trias Renegade LP-AT Taleo LP SACH-foot Sole Kit 1E90 Sprinter Axtion DP Triton Harmony Sliding Adaptor -Titanium- Taleo Footshell SACH Foot,Child,Medium Taleo VS, Taleo Harmony SACH Foot FitKit WalkOn Lateral Junior FitKit WalkOn Lateral Heel wedges 10 degrees, 16 degrees, 22 degrees X-ible flexible ankle joints WalkOn Fit Kit Mulfifunction correction system joints WalkOn Flex Fit Kit Dual Function Ankle Joint Nexgear extension bars Multifunctional system ankle joint Infinity Air Walker, high System-toe Pick-up Ank.Jt. Malleo TriStep Ankle Orthosis Ankle Support Active Contour Ankle Joint Dyna Ankle - Dynamic Ankle Orthosis Concealed Spring Ankle Joint WalkOn Trimable Infinity Air Walker, low Malleo Neurexa System-Limit Mot Ankle Jt. WalkOn Reaction Malleo Sprint WalkOn Reaction Fit Kit WalkOn Reaction Plus Fit Kit Carbon Ankle Seven System Ankle Joint With Lam. Set Walk On Flex Malleo Immobil Night Splint FitKit WalkOn Reaction Lateral FitKit WalkOn Flex Junior Nexgear Tango Ankle Joint Nexgear side bar bilateral GoOn Achillo Sensa WalkOn Reaction Plus, Junior Malleo Sensa Heel wedges 15 degrees, 30 degrees Malleo Direxa Stirrup Unilateral Ankle Joint Walk-On AFO Medial joint for correction joint Reaction modul Foot stirrup WalkOn lateral Nexgear lamination bar bilateral WalkOn Reaction lateral Malleo Neurexa pro Heel Relief Orthosis Des. By Dr. Settner Smartspine SI Support Extension Orthosis Postural Extension Cyberspine TLSOx4 Ottobock TLSO Dosi EQ Smartspine Extension Brace Cybercross TLSO MyCRO Band

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2018-04-09
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	Class 1	890.3420	2005-05-12
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2005-07-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2005-09-26
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2021-03-26
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2021-03-26
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2005-07-28
ISW	Assembly, Knee/Shank/Ankle/Foot, External	Physical Medicine	Class 2	890.3500	2004-12-29
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2005-07-28
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2005-07-28
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2005-07-28
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2022-06-09
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2022-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ottobock SE & Co. KGaA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007923118	Otto Bock Mobility Solutions GmbH	Koenigsee Thuringia, DE
9681725	Otto Bock Manufacturing Konigsee GmbH	Koenigsee Thuringia, DE
3001917653	OTTO BOCK ITALIA SRL	BUDRIO Bologna, IT
9611742	OTTO BOCK (CHINA) INDUSTRIES CO., LTD.	BEIJING, CN
3018070833	Ottobock Manufacturing Bulgaria EOOD	Blagoevgrad, BG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721652. Last updated year: 2026. Please use registration number 1721652 when referencing this establishment in official correspondence.