Halo Traction Cervical Immobilization
FDA 510(k) K822885 · Orthopedic Systems, Inc.
510(k) numberK822885
Submission
- Device name
- Halo Traction Cervical Immobilization
- Applicant
- Orthopedic Systems, Inc.
Walker, MI, US - Received
- September 28, 1982
- Decision date
- November 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090733 | PMT Halo SystemHAX · Traditional | Pmt Corp. | 07/28/2009SE |
| K071173 | Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100DHAX · Special | Ossur Americans (Formerly the Jerome Group) | 05/25/2007SE |
| K051918 | Resolve Open Back Halo RingsHAX · Special | Jerome Medical | 08/17/2005SE |
| K023959 | Jerome Glass RingHAX · Traditional | The Jerome Group, Inc. | 02/21/2003SE |
| K003662 | Spine Works CollarHAX · Traditional | Spine Works | 07/09/2001SE |
| K980689 | Friddle Halo System, Friddle MRI Halo SystemHAX · Traditional | Friddle'S Orthopedic Appliances, Inc. | 02/18/1999SE |
| K930021 | J TongsHAX · Traditional | Jerome Medical | 12/06/1995SE |
| K954069 | Ace Cervical Traction Halozs, Tongs & PinsHAX · Traditional | Ace Medical Co. | 10/12/1995SE |
| K924606 | Bremer Imaging Tongs-Mri ModelHAX · Traditional | Bremer Medical, Inc. | 09/09/1993SE |
| K915530 | Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional | American Threshold Industries, Inc. | 08/17/1992SE |
More from American Threshold Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Halo Traction Cervical Immobilization cleared by the FDA?
Halo Traction Cervical Immobilization (K822885) received a 510(k) decision of Substantially Equivalent on November 22, 1982, 55 days after the submission was received.
What is the product code of K822885?
The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.