Atlas FDA

HST

38 FDA 510(k) clearances · Product code

23 daysmedian time to decision
93 days90th percentile
38clearances measured

FDA profile

Official device name
Apparatus, Traction, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 888.5850
Medical specialty
Orthopedic
Flags
GMP exempt
Adverse events (MAUDE)
2021: 40 · 2022: 26 · 2023: 18 · 2024: 47 · 2025: 20 · 2026: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table (K162702)Stl International, Inc.2016-12-30
LO-BAK TRAX (K110858)Roland F Berthiaume, DC2011-08-02
BACK-ON-TRAC, MODEL 101BOT (K984190)Back-On-Track, Inc.1999-03-15
K AND D HOME TRACT (K872121)Joseph A. Kott, M.D.1987-08-12
ARTHROSCOPIC SHOULDER HOLDER (K870212)Dyonics, Inc.1987-02-20
EXTREMITY ELEVATOR (K870125)Orthopedic Systems, Inc.1987-02-04
TUPPER TROLLEY (K870102)Orthopedic Systems, Inc.1987-02-03
MODEL 668, TRACTION SPLINT, ADULT (K864765)Ferno-Washington, Inc.1986-12-17
THE TOWERED 90/90 UNIT (K862874)Lossing Orthopedic, Inc.1986-08-07
TRANSFER-TRAX (TM) SPLINT TRACTION (K855179)Comfortex, Inc.1986-01-21
SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (K860037)Comfortex, Inc.1986-01-21
NEC-KRADLE BY VENCOR (K844239)Vencor1984-11-19
HYPERBARIC OXYGEN GURNEY- (K841368)Orthopedic Systems, Inc.1984-05-16
ACUFEX SHOULDER HOLDER (K841388)Acufex Microsurgical, Inc.1984-05-16
COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG (K831888)Portable Travtion Device Co.1983-07-12
TRACTION ACCESSORIES (K830244)Warm & Form, Orthopedic Materials1983-03-09
TRACTION ACCESSORIES (K823813)Danek Medical, Inc.1983-01-14
TRACTION-STEEL FRAMING SYSTEM (K823395)Orthopedic Systems, Inc.1982-12-03
OCTAGONAL ALUMINUM FRAMING SYSTEM (K823372)Orthopedic Systems, Inc.1982-12-03
FOREARM REDUCTION UNIT (K823392)Orthopedic Systems, Inc.1982-11-29
SENATEK (K822993)American Health Tech., Inc.1982-10-26
CERVITRAC TRACTION FRAME & CORD (K821522)George W. Cottrell1982-06-21
TENSOPLAST SKIN TRACTION KIT (K820612)Smith & Nephew, Inc.1982-03-31
NECKTRAC (K813017)Lossing Orthopedic, Inc.1981-11-25
ZEE TRACTION SPLINT (K813016)Zee Medical Products Co., Inc.1981-11-24
EXTENSIONS-LUSATZTISCH (K812779)The Telos Co.1981-10-26
UPPER EXTREMITY TRACTION DEVICE (K803021)Orthopedic Systems, Inc.1980-12-12
COTTRELL 90/90 BACKTRAC (K802555)Lossing Orthopedic, Inc.1980-10-31
PROT-A-TRAC (K802072)Robert I. Branick, M.D.1980-09-26
TAYLOR TRACTION CORD (K792248)Taylor Medical Equipment1979-11-30
BAC JAC (K791919)Haggin Industries, Inc.1979-10-04
MEDI-TRAK PORTABLE TRACTION DEVICE (K791396)Medicorp, Inc.1979-08-16
OCTAGONAL ALUMINUM FRAMING SYSTEM (K790729)Orthopedic Systems, Inc.1979-05-01
VERTETRAC (K771988)Ballert Orthopedic Corp.1979-02-01
BACK TRAC (K781647)Tech Engineering, Inc.1978-10-17
TRACTION WEIGHT BAGS (K780233)Biomet, Inc.1978-02-23
TRACTION UNITS (K780228)Biomet, Inc.1978-02-23
BAKER MOBILE TRACTION (K770080)Orthopedic Equipment Co., Inc.1977-01-25

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Every clearance here is in the API, with alerts when new ones post.