JMS Cervical Traction Device/Halo Device
FDA 510(k) K882877 · Jerome Medical
510(k) numberK882877
Submission
- Device name
- JMS Cervical Traction Device/Halo Device
- Applicant
- Jerome Medical
Mt Laurel, NJ, US - Received
- July 11, 1988
- Decision date
- September 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JEC – Component, Traction, Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JEC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203605 | SteriTrakJEC · Traditional | Arbutus Medical, Inc. | 04/23/2021SE |
| K193256 | Anjon Bremer Halo SystemJEC · Traditional | Anjon Holdings, LLC | 03/02/2020SE |
| K192465 | DigiFix Sterile KitJEC · Special | Virak Orthopedics, LLC | 10/10/2019SE |
| K181192 | PIP FixJEC · Traditional | Hand Biomechanics Lab, Inc. | 10/22/2018SE |
| K171863 | Anjon Bremer Halo SystemJEC · Traditional | Anjon Holdings, LLC | 03/19/2018SE |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation DevicesJEC · Traditional | Surgical Instrument Service and Savings, Inc. | 12/28/2016SE |
| K132731 | Digifix External Fixation SystemJEC · Traditional | Virak Orthopedic Research, LLC | 01/10/2014SE |
| K102885 | Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020…JEC · Special | Stryker Corp. | 01/14/2011SE |
| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | Sintea Biotech, Inc. | 04/07/2009SE |
| K072432 | F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non SterileJEC · Traditional | Hand Biomechanics Lab, Inc. | 01/09/2008SE |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051918 | Resolve Open Back Halo RingsHAX · Special | 08/17/2005SE |
| K930021 | J TongsHAX · Traditional | 12/06/1995SE |
| K930153 | System III Halo RingJEC · Traditional | 08/06/1993SE |
| 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 JMS Cervical Traction Device/Halo Device cleared by the FDA?
JMS Cervical Traction Device/Halo Device (K882877) received a 510(k) decision of Substantially Equivalent on September 30, 1988, 81 days after the submission was received.
What is the product code of K882877?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.