Friddle Halo System, Friddle MRI Halo System
FDA 510(k) K980689 · Friddle'S Orthopedic Appliances, Inc.
510(k) numberK980689
Submission
- Device name
- Friddle Halo System, Friddle MRI Halo System
- Applicant
- Friddle'S Orthopedic Appliances, Inc.
Honea Path, SC, US - Received
- February 23, 1998
- Decision date
- February 18, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K873693 | Levtech Composite Traction TongsHAX · Traditional | Levtech, Inc. | 02/05/1988SE |
Questions and answers
When was Friddle Halo System, Friddle MRI Halo System cleared by the FDA?
Friddle Halo System, Friddle MRI Halo System (K980689) received a 510(k) decision of Substantially Equivalent on February 18, 1999, 360 days after the submission was received.
What is the product code of K980689?
The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.