Cervical Brace
FDA 510(k) K822780 · Jerome Medical
510(k) numberK822780
Submission
- Device name
- Cervical Brace
- Applicant
- Jerome Medical
Mchenry, IL, US - Received
- September 14, 1982
- Decision date
- October 6, 1982
- 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
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| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | Sintea Biotech, Inc. | 04/07/2009SE |
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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 |
| 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 |
| K821582 | Warm'N Form Sports SupportsIQI · Traditional | 06/10/1982SE |
Questions and answers
When was Cervical Brace cleared by the FDA?
Cervical Brace (K822780) received a 510(k) decision of Substantially Equivalent on October 6, 1982, 22 days after the submission was received.
What is the product code of K822780?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.