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Orthosis, Limb Brace

FDA product code IQI · 51 cleared devices

Class 1 Physical Medicine

Regulation: 21 CFR 890.3475
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: Yes
Clearance span: 1976-07-26 – 2006-05-03

IQI 2006-05-03

SENSOR WALK

Applicant Otto Bock Healthcare LP

K number K052771

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IQI 2003-07-31

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

Applicant Surgitech, Inc.

K number K031576

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IQI 1993-07-22

ACCUFLEX DYNAMIC ELBOW ORTHOSIS

Applicant Regulatory & Marketing Services, Inc.

K number K926391

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IQI 1991-03-21

MCCONNELL SHOULDER BRACE

Applicant Mcconnell Orthopedic

K number K910974

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IQI 1987-11-30

GAIT-AID ORTHOPEDIC INSOLE

Applicant Gait-Aid, Inc.

K number K874502

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IQI 1983-06-24

ADJUSTABLE POLYCENTRIC ELBOW HINGE

Applicant Fred Sammons, Inc.

K number K831542

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IQI 1983-06-15

DROP FOOT BRACE

Applicant Edward Dilauro, Jr.

K number K831615

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IQI 1983-01-14

VARIOUS SUPPORTS AND SPLINTS

Applicant Danek Medical, Inc.

K number K823812

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IQI 1982-11-16

BRACE-UP ALL PURPOSE WRIST BAND

Applicant Arco Matic, Inc.

K number K823113

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IQI 1982-11-10

ROTATION BOOT

Applicant Warm & Form, Orthopedic Materials

K number K823160

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IQI 1982-11-05

BRACE-UP STOCKING KNEE BRACE

Applicant Arco Matic, Inc.

K number K823114

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IQI 1982-10-06

UNIVERSAL DYNASPLINT

Applicant Dynasplint Systems, Inc.

K number K822767

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IQI 1982-07-26

SPORT SUPPORTS

Applicant Ginny, Inc.

K number K822022

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IQI 1982-06-24

FRACTURE BRACING

Applicant Hosmer Dorrance Corp.

K number K821704

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IQI 1982-06-11

OBTHOSES

Applicant Fred Sammons, Inc.

K number K821641

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IQI 1982-06-11

ORTHOTIC FABRICATION ACCESSORIES

Applicant Fred Sammons, Inc.

K number K821640

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IQI 1982-06-10

WARM'N FORM SPORTS SUPPORTS

Applicant Jerome Medical

K number K821582

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IQI 1982-03-08

WARM & FORM KNEE SUPPORTS

Applicant Thermo-Mold Medical Products, Inc.

K number K820469

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IQI 1981-07-01

MULTITUBULAR AIR SPLINT KIT

Applicant Roger Cestac & Assoc.

K number K811704

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IQI 1981-06-25

ANKLE-FOOT CAST/SPLINT

Applicant Surgical Appliance Industries, Inc.

K number K811690

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IQI 1981-06-12

FOREARM & KNEE STRAPS

Applicant Fred Sammons, Inc.

K number K811490

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IQI 1981-06-12

ORTHO-FRAC KIT

Applicant Orthomedics

K number K811456

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IQI 1981-05-28

HUMERAL FRACTURE CAST BRACE

Applicant Deseret Medical, Inc.

K number K811343

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IQI 1981-04-29

PRO COMFORT TENNIS ELBOW SUPPORT/WRIST

Applicant Scholl, Inc.

K number K811035

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IQI 1981-03-04

LIMB ORTHOSIS

Applicant Fred Sammons, Inc.

K number K810443

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IQI 1981-02-12

AIRCAST TENNIS ARM BAND

Applicant Aircast, Inc.

K number K810288

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IQI 1980-12-22

PLASTIC FRACTURE CAST BRACE KNEE JOINT

Applicant Orthomedics

K number K802910

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IQI 1980-12-17

HUMERAL FRACTURE BRACE

Applicant Orthomedics

K number K802909

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IQI 1980-12-17

ULNAR FRACTURE BRACE

Applicant Orthomedics

K number K802908

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IQI 1980-12-11

TIBIAL FRACTURE BRACE

Applicant Orthomedics

K number K802871

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IQI 1980-09-16

C-SPLINT

Applicant Cutter Laboratories, Inc.

K number K802104

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IQI 1980-08-07

HUMEROUS FRACTURE BRACE, ULNA FRACTURE

Applicant Hosmer Dorrance Corp.

K number K801788

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IQI 1980-08-07

BK-1520-01 ECONOMY WRIST SUPPORT, CHILD

Applicant Fred Sammons, Inc.

K number K801708

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IQI 1980-08-07

BAUER & BLACK RIGID WRIST BRACE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K801701

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IQI 1980-05-02

OHC DYNAMIC CLUB FOOT BRACE

Applicant Ipos Luneburg

K number K800715

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IQI 1979-08-28

PARAPODIUM

Applicant Physico-Medical Systems Corp.

K number K791565

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IQI 1979-07-24

SECUTEX ANKLE BAND

Applicant Conphar, Inc.

K number K791267

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IQI 1979-07-24

SECUTEX KNEE BAND

Applicant Conphar, Inc.

K number K791266

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IQI 1979-07-24

SECUTEX WRIST BRACE

Applicant Conphar, Inc.

K number K791249

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IQI 1979-07-24

SECUTE ELBOW BAND

Applicant Conphar, Inc.

K number K791248

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IQI 1979-06-20

CAST BRACE COMPONENTS

Applicant 3M Company

K number K791057

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IQI 1978-07-31

FOOT POSITIONER

Applicant Fred Sammons, Inc.

K number K781206

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IQI 1978-06-30

AIRSTIRRUP PNEUMATIC ANKLE BRACE

Applicant Aircast, Inc.

K number K780979

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IQI 1978-02-24

ORTHOSISES DEVICES

Applicant Biomet, Inc.

K number K780225

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IQI 1978-01-17

BRACE, TENNIS ELBOW

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K780053

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IQI 1977-09-20

FOOT DROP BOOT

Applicant Medical Restraints, Inc.

K number K771676

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IQI 1977-04-08

SPLINT, BOHLER

Applicant Will Ross Co.

K number K770612

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IQI 1977-01-28

KNEE SEPARATOR

Applicant Bel-Art Products

K number K770167

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IQI 1977-01-10

ORTHOTIC BRACING

Applicant Hosmer Dorrance Corp.

K number K761312

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IQI 1976-11-11

DEVON KNEE STRAP

Applicant Devon Industries, Inc.

K number K760950

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IQI 1976-07-26

KNEE AID

Applicant Zimmer, Inc.

K number K760002

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