Atlas FDA

IQI

52 FDA 510(k) clearances · Product code

17 daysmedian time to decision
43 days90th percentile
52clearances measured

FDA profile

Official device name
Orthosis, Limb Brace
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
2015: 20 · 2016: 14 · 2017: 93 · 2018: 19 · 2019: 19 · 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Neurosplint (K143458)Neurospectrum, LLC2015-08-13
SENSOR WALK (K052771)Otto Bock Healthcare LP2006-05-03
SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576)Surgitech, Inc.2003-07-31
ACCUFLEX DYNAMIC ELBOW ORTHOSIS (K926391)Regulatory & Marketing Services, Inc.1993-07-22
MCCONNELL SHOULDER BRACE (K910974)Mcconnell Orthopedic1991-03-21
GAIT-AID ORTHOPEDIC INSOLE (K874502)Gait-Aid, Inc.1987-11-30
ADJUSTABLE POLYCENTRIC ELBOW HINGE (K831542)Fred Sammons, Inc.1983-06-24
DROP FOOT BRACE (K831615)Edward Dilauro, Jr.1983-06-15
VARIOUS SUPPORTS AND SPLINTS (K823812)Danek Medical, Inc.1983-01-14
BRACE-UP ALL PURPOSE WRIST BAND (K823113)Arco Matic, Inc.1982-11-16
ROTATION BOOT (K823160)Warm & Form, Orthopedic Materials1982-11-10
BRACE-UP STOCKING KNEE BRACE (K823114)Arco Matic, Inc.1982-11-05
UNIVERSAL DYNASPLINT (K822767)Dynasplint Systems, Inc.1982-10-06
SPORT SUPPORTS (K822022)Ginny, Inc.1982-07-26
FRACTURE BRACING (K821704)Hosmer Dorrance Corp.1982-06-24
OBTHOSES (K821641)Fred Sammons, Inc.1982-06-11
ORTHOTIC FABRICATION ACCESSORIES (K821640)Fred Sammons, Inc.1982-06-11
WARM'N FORM SPORTS SUPPORTS (K821582)Jerome Medical1982-06-10
WARM & FORM KNEE SUPPORTS (K820469)Thermo-Mold Medical Products, Inc.1982-03-08
MULTITUBULAR AIR SPLINT KIT (K811704)Roger Cestac & Assoc.1981-07-01
ANKLE-FOOT CAST/SPLINT (K811690)Surgical Appliance Industries, Inc.1981-06-25
FOREARM & KNEE STRAPS (K811490)Fred Sammons, Inc.1981-06-12
ORTHO-FRAC KIT (K811456)Orthomedics1981-06-12
HUMERAL FRACTURE CAST BRACE (K811343)Deseret Medical, Inc.1981-05-28
PRO COMFORT TENNIS ELBOW SUPPORT/WRIST (K811035)Scholl, Inc.1981-04-29
LIMB ORTHOSIS (K810443)Fred Sammons, Inc.1981-03-04
AIRCAST TENNIS ARM BAND (K810288)Aircast, Inc.1981-02-12
PLASTIC FRACTURE CAST BRACE KNEE JOINT (K802910)Orthomedics1980-12-22
ULNAR FRACTURE BRACE (K802908)Orthomedics1980-12-17
HUMERAL FRACTURE BRACE (K802909)Orthomedics1980-12-17
TIBIAL FRACTURE BRACE (K802871)Orthomedics1980-12-11
C-SPLINT (K802104)Cutter Laboratories, Inc.1980-09-16
HUMEROUS FRACTURE BRACE, ULNA FRACTURE (K801788)Hosmer Dorrance Corp.1980-08-07
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD (K801708)Fred Sammons, Inc.1980-08-07
BAUER & BLACK RIGID WRIST BRACE (K801701)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-08-07
OHC DYNAMIC CLUB FOOT BRACE (K800715)Ipos Luneburg1980-05-02
PARAPODIUM (K791565)Physico-Medical Systems Corp.1979-08-28
SECUTE ELBOW BAND (K791248)Conphar, Inc.1979-07-24
SECUTEX KNEE BAND (K791266)Conphar, Inc.1979-07-24
SECUTEX ANKLE BAND (K791267)Conphar, Inc.1979-07-24
SECUTEX WRIST BRACE (K791249)Conphar, Inc.1979-07-24
CAST BRACE COMPONENTS (K791057)3M Company1979-06-20
FOOT POSITIONER (K781206)Fred Sammons, Inc.1978-07-31
AIRSTIRRUP PNEUMATIC ANKLE BRACE (K780979)Aircast, Inc.1978-06-30
ORTHOSISES DEVICES (K780225)Biomet, Inc.1978-02-24
BRACE, TENNIS ELBOW (K780053)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-01-17
FOOT DROP BOOT (K771676)Medical Restraints, Inc.1977-09-20
SPLINT, BOHLER (K770612)Will Ross Co.1977-04-08
KNEE SEPARATOR (K770167)Bel-Art Products1977-01-28
ORTHOTIC BRACING (K761312)Hosmer Dorrance Corp.1977-01-10
DEVON KNEE STRAP (K760950)Devon Industries, Inc.1976-11-11
KNEE AID (K760002)Zimmer, Inc.1976-07-26

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