Atlas FDA

ILH

36 FDA 510(k) clearances · Product code

18 daysmedian time to decision
46 days90th percentile
36clearances measured

FDA profile

Official device name
Splint, Hand, And Components
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
1993: 1 · 1995: 1 · 1997: 1 · 1999: 1 · 2011: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SPLINT WOOD (K832144)Vermont Wood Industries, Inc.1983-08-01
SPLINTS (K831548)Fred Sammons, Inc.1983-06-27
FINGER EXTENSION SPLINT (K823647)Fred Sammons, Inc.1983-01-21
FINGER FLEXION SPLINT (K823644)Fred Sammons, Inc.1983-01-21
UNIVERSAL WRIST SPLINT & FOREARM SPLINT (K823666)Warm & Form, Orthopedic Materials1982-12-30
WRIST SUPPORT (K823601)Fred Sammons, Inc.1982-12-22
STAX FINGER SPLINTS (K823393)Orthopedic Systems, Inc.1982-12-03
WRIST SPLING & FOREARM SPLINT (K823165)Warm & Form, Orthopedic Materials1982-11-16
TOTAL FINGER FLEXION SPLINT (K822651)Alimed, Inc.1982-09-17
WIRE-FOAM MP FLEXION SPRING (K821637)Fred Sammons, Inc.1982-06-11
SOFT ULNAR DEVIATION SPLINTS (K821635)Fred Sammons, Inc.1982-06-11
STAX FINGER SPLINT (K820826)Conco Medical Co.1982-04-08
FINGER PROTECTOR (K820381)Conco Medical Co.1982-03-01
CURVED FINGER SPLINT (K820380)Conco Medical Co.1982-03-01
FROG SPLINT (K820382)Conco Medical Co.1982-03-01
FINGER COT (K820383)Conco Medical Co.1982-02-24
VELCRO FINGER/TOE SPLINT (K812654)Maddak, Inc.1981-09-25
VELCRO SPLINT STRAP FASTENERS (K812655)Maddak, Inc.1981-09-25
HAND SPLINTS & COMPONENTS (K812349)Fred Sammons, Inc.1981-09-11
HAND SPLINTS AND COMPONENTS (K810442)Fred Sammons, Inc.1981-03-04
METAL SPLINTS (K810109)Secol Co.1981-01-26
BK-1499 KAY-KPLINT HAND CONE/BK-1500 (K801707)Fred Sammons, Inc.1980-08-20
TRANS DISTAL JOINT FINGER EXTEN. SPLINT (K801714)Fred Sammons, Inc.1980-08-07
DYNAMIC EXTENSOR SPLINT (K800143)Biomet, Inc.1980-02-19
2 VELCRO SPLINT STRAP (K790182)Fred Sammons, Inc.1979-02-15
SOFT SPLINT STRAPS (K790181)Fred Sammons, Inc.1979-02-13
PLATFORM SPLINTS (K790180)Fred Sammons, Inc.1979-02-13
PRE-FORMED SPLINT BLANKS (K772416)Fred Sammons, Inc.1978-01-05
PLATFORM SPLINTS (K772411)Fred Sammons, Inc.1978-01-05
RESTING PAN SPLINTS (K772410)Fred Sammons, Inc.1978-01-05
SPLINTS, FINGER/TOE (K770786)Depuy, Inc.1977-05-18
SAFETY PIN SPLINT (K761131)Fred Sammons, Inc.1976-12-02
PLASTIC FINGER CUFFS (K761134)Fred Sammons, Inc.1976-12-02
STRIP, CLOSED CELL FOAM, BK-7171 (K760299)Fred Sammons, Inc.1976-09-08
PADDING, TEMPER STICK FOAM, BK-7175 (K760300)Fred Sammons, Inc.1976-09-08
SUPPORT, WRIST, FIRM WIRE-FOAM (K760298)Fred Sammons, Inc.1976-09-08

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