J Tongs
FDA 510(k) K930021 · Jerome Medical
510(k) numberK930021
Submission
- Device name
- J Tongs
- Applicant
- Jerome Medical
Mt Laurel, NJ, US - Received
- January 5, 1993
- Decision date
- December 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K980689 | Friddle Halo System, Friddle MRI Halo SystemHAX · Traditional | Friddle'S Orthopedic Appliances, Inc. | 02/18/1999SE |
| 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 |
More from Levtech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051918 | Resolve Open Back Halo RingsHAX · Special | 08/17/2005SE |
| K930153 | System III Halo RingJEC · Traditional | 08/06/1993SE |
| K882877 | JMS Cervical Traction Device/Halo DeviceJEC · Traditional | 09/30/1988SE |
| K870053 | Torquedriver WrenchHXC · Traditional | 03/11/1987SE |
| K864969 | JMS Halo Application TrayKDD · Traditional | 02/18/1987SESD |
| K844490 | Traction AccessoriesILZ · Traditional | 02/21/1985SE |
| K822780 | Cervical BraceJEC · Traditional | 10/06/1982SE |
| K821582 | Warm'N Form Sports SupportsIQI · Traditional | 06/10/1982SE |
Questions and answers
When was J Tongs cleared by the FDA?
J Tongs (K930021) received a 510(k) decision of Substantially Equivalent on December 6, 1995, 1,065 days after the submission was received.
What is the product code of K930021?
The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.