Halo Support Jacket & Assoc. Hardware
FDA 510(k) K792586 · Depuy, Inc.
510(k) numberK792586
Submission
- Device name
- Halo Support Jacket & Assoc. Hardware
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- December 17, 1979
- Decision date
- December 31, 1979
- 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 |
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| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
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Questions and answers
When was Halo Support Jacket & Assoc. Hardware cleared by the FDA?
Halo Support Jacket & Assoc. Hardware (K792586) received a 510(k) decision of Substantially Equivalent on December 31, 1979, 14 days after the submission was received.
What is the product code of K792586?
The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.