Product code HST
- Device name
- Apparatus, Traction, Non-Powered
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.5850
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table | Stl International, Inc. | 2016-12-30 |
| K110858 | LO-BAK TRAX | Roland F Berthiaume, DC | 2011-08-02 |
| K984190 | BACK-ON-TRAC, MODEL 101BOT | Back-On-Track, Inc. | 1999-03-15 |
| K872121 | K AND D HOME TRACT | Joseph A. Kott, M.D. | 1987-08-12 |
| K870212 | ARTHROSCOPIC SHOULDER HOLDER | Dyonics, Inc. | 1987-02-20 |
| K870125 | EXTREMITY ELEVATOR | Orthopedic Systems, Inc. | 1987-02-04 |
| K870102 | TUPPER TROLLEY | Orthopedic Systems, Inc. | 1987-02-03 |
| K864765 | MODEL 668, TRACTION SPLINT, ADULT | Ferno-Washington, Inc. | 1986-12-17 |
| K862874 | THE TOWERED 90/90 UNIT | Lossing Orthopedic, Inc. | 1986-08-07 |
| K860037 | SUSPENDER ORTHOPEDIC SUSPENSION DEVICE | Comfortex, Inc. | 1986-01-21 |
| K855179 | TRANSFER-TRAX (TM) SPLINT TRACTION | Comfortex, Inc. | 1986-01-21 |
| K844239 | NEC-KRADLE BY VENCOR | Vencor | 1984-11-19 |
| K841388 | ACUFEX SHOULDER HOLDER | Acufex Microsurgical, Inc. | 1984-05-16 |
| K841368 | HYPERBARIC OXYGEN GURNEY- | Orthopedic Systems, Inc. | 1984-05-16 |
| K831888 | COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG | Portable Travtion Device Co. | 1983-07-12 |
| K830244 | TRACTION ACCESSORIES | Warm & Form, Orthopedic Materials | 1983-03-09 |
| K823813 | TRACTION ACCESSORIES | Danek Medical, Inc. | 1983-01-14 |
| K823395 | TRACTION-STEEL FRAMING SYSTEM | Orthopedic Systems, Inc. | 1982-12-03 |
| K823372 | OCTAGONAL ALUMINUM FRAMING SYSTEM | Orthopedic Systems, Inc. | 1982-12-03 |
| K823392 | FOREARM REDUCTION UNIT | Orthopedic Systems, Inc. | 1982-11-29 |
| K822993 | SENATEK | American Health Tech., Inc. | 1982-10-26 |
| K821522 | CERVITRAC TRACTION FRAME & CORD | George W. Cottrell | 1982-06-21 |
| K820612 | TENSOPLAST SKIN TRACTION KIT | Smith & Nephew, Inc. | 1982-03-31 |
| K813017 | NECKTRAC | Lossing Orthopedic, Inc. | 1981-11-25 |
| K813016 | ZEE TRACTION SPLINT | Zee Medical Products Co., Inc. | 1981-11-24 |
| K812779 | EXTENSIONS-LUSATZTISCH | The Telos Co. | 1981-10-26 |
| K803021 | UPPER EXTREMITY TRACTION DEVICE | Orthopedic Systems, Inc. | 1980-12-12 |
| K802555 | COTTRELL 90/90 BACKTRAC | Lossing Orthopedic, Inc. | 1980-10-31 |
| K802072 | PROT-A-TRAC | Robert I. Branick, M.D. | 1980-09-26 |
| K792248 | TAYLOR TRACTION CORD | Taylor Medical Equipment | 1979-11-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327570465 | Pivot Guardian | STRYKER CORPORATION | 2022-06-01 |
| 07613327570472 | Pivot Guardian | STRYKER CORPORATION | 2022-06-01 |
| 07613327570489 | Pivot Guardian | STRYKER CORPORATION | 2022-06-01 |
| 10845854013229 | DIGIT TRAP | Conmed Corporation | 2021-10-11 |
| 10845854017890 | DIGIT TRAP | Conmed Corporation | 2021-10-11 |
| 10845854024737 | CONMED | Conmed Corporation | 2021-10-06 |
| 10724995165397 | NA | STERIS CORPORATION | 2021-04-23 |
| 10724995191242 | NA | STERIS CORPORATION | 2021-04-23 |
| 10845854026199 | CONMED | Conmed Corporation | 2020-09-24 |
| 10845854026236 | BEACH CHAIR | Conmed Corporation | 2020-09-24 |
| 07613327376340 | PostFree | STRYKER CORPORATION | 2017-08-31 |
| 10886982200280 | NA | Synthes GmbH | 2016-12-31 |
| 10886982200273 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199720 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199713 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199706 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199690 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199683 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199676 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199553 | NA | Synthes GmbH | 2016-12-31 |
| 10886982199430 | NA | Synthes GmbH | 2016-12-31 |
| 10886982196071 | NA | Synthes GmbH | 2016-12-31 |
| 10886982196057 | NA | Synthes GmbH | 2016-12-31 |
| 10886982071255 | NA | Synthes GmbH | 2016-12-31 |
| 10886982071248 | NA | Synthes GmbH | 2016-12-31 |
| 10886982071231 | NA | Synthes GmbH | 2016-12-31 |
| 10886982071224 | NA | Synthes GmbH | 2016-12-31 |
| 10886982006608 | NA | Synthes GmbH | 2016-12-31 |
| 10886982006035 | NA | Synthes GmbH | 2016-12-31 |
| 10705034718385 | NA | Synthes GmbH | 2016-12-31 |