Traction Accessories
FDA 510(k) K823813 · Danek Medical, Inc.
510(k) numberK823813
Submission
- Device name
- Traction Accessories
- Applicant
- Danek Medical, Inc.
Mchenry, IL, US - Received
- December 17, 1982
- Decision date
- January 14, 1983
- 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 |
| K864765 | Model 668, Traction Splint, AdultHST · Traditional | Ferno-Washington, Inc. | 12/17/1986SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | Lossing Orthopedic, Inc. | 08/07/1986SE |
| K860037 | Suspender Orthopedic Suspension DeviceHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
More from Comfortex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994122 | Bone Graft Washer, Model 9090114 - 9090118KWQ · Traditional | 02/18/2000SE |
| K993810 | CD Horizon Spinal SystemMNH · Special | 02/03/2000SE |
| K993855 | Atlantis Anterior Cervical Plate SystemKWQ · Special | 12/15/1999SE |
| K991528 | Modification to Tenor Spinal System-Rod/Bolt ConnectorMNH · Special | 05/28/1999SE |
| K990603 | Modification of the Zplate-Atl Anterior Fixation SystemKWQ · Special | 03/10/1999SE |
| K982875 | Modification to Zplate-Atl Anterior Fixation SystemKWQ · Special | 01/19/1999SE |
| K984522 | Modification of TSRH Spinal SystemMNI · Special | 01/06/1999SE |
| K982154 | Modification of Townley Pedicle Screw Plating SystemMNI · Special | 07/13/1998SE |
| K970599 | Townley Pedicle Screw Plating SystemMNI · Traditional | 03/20/1998SE |
| K943827 | Spine FixationMNH · Traditional | 02/14/1996SN |
Questions and answers
When was Traction Accessories cleared by the FDA?
Traction Accessories (K823813) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 28 days after the submission was received.
What is the product code of K823813?
The FDA product code is HST – Apparatus, Traction, Non-Powered, a Class I (low risk) device regulated under 21 CFR 888.5850.