Model 668, Traction Splint, Adult
FDA 510(k) K864765 · Ferno-Washington, Inc.
510(k) numberK864765
Submission
- Device name
- Model 668, Traction Splint, Adult
- Applicant
- Ferno-Washington, Inc.
Wilmington, OH, US - Received
- December 5, 1986
- Decision date
- December 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HST – Apparatus, Traction, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5850
- Specialty
- Orthopedic
Other 510(k)s with product code HST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…HST · Traditional | Stl International, Inc. | 12/30/2016SE |
| K110858 | Lo-Bak TraxHST · Traditional | Roland F Berthiaume, DC | 08/02/2011SE |
| K984190 | Back-On-Trac, Model 101BOTHST · Traditional | Back-On-Track, Inc. | 03/15/1999SE |
| K872121 | K and D Home TractHST · Traditional | Joseph A. Kott, M.D. | 08/12/1987SE |
| K870212 | Arthroscopic Shoulder HolderHST · Traditional | Dyonics, Inc. | 02/20/1987SE |
| K870125 | Extremity ElevatorHST · Traditional | Orthopedic Systems, Inc. | 02/04/1987SE |
| K870102 | Tupper TrolleyHST · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | Lossing Orthopedic, Inc. | 08/07/1986SE |
| K860037 | Suspender Orthopedic Suspension DeviceHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
| K855179 | Transfer-Trax (TM) Splint TractionHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
More from Comfortex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980033 | Ferno Healthcare Recline-A-Bath 2ILJ · Traditional | 04/21/1998SE |
| K932417 | Ferno Washington Incubator Transporter, Mod. 35-ITFPL · Traditional | 09/09/1993SE |
| K864269 | Model 35-B All Level CotFPO · Traditional | 11/13/1986SE |
| K862441 | Ez Load Model 30, All Level CotFPO · Traditional | 09/12/1986SE |
Questions and answers
When was Model 668, Traction Splint, Adult cleared by the FDA?
Model 668, Traction Splint, Adult (K864765) received a 510(k) decision of Substantially Equivalent on December 17, 1986, 12 days after the submission was received.
What is the product code of K864765?
The FDA product code is HST – Apparatus, Traction, Non-Powered, a Class I (low risk) device regulated under 21 CFR 888.5850.