Crusader Hyperextension Brace
FDA 510(k) K803033 · Orthomedics
510(k) numberK803033
Submission
- Device name
- Crusader Hyperextension Brace
- Applicant
- Orthomedics
Mchenry, IL, US - Received
- December 1, 1980
- Decision date
- December 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IPY – Orthosis, Lumbo-Sacral
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Specialty
- Physical Medicine
Other 510(k)s with product code IPY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K823882 | M-BraceIPY · Traditional | Buckman Consultants | 01/17/1983SE |
| K823823 | Lumbosacral SupportIPY · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K812422 | Custom Contour Lumbosacral OrthosisIPY · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812099 | Cash OrthosisIPY · Traditional | David Hendricks, C.P.O. | 08/13/1981SE |
| K811494 | Lumbo-Sacral Flexion OrthosisIPY · Traditional | Surgical Appliance Industries, Inc. | 06/16/1981SE |
| K810556 | Spinal Extension BraceIPY · Traditional | Orthomedics | 03/13/1981SE |
| K810554 | Lumbar Flexion BraceIPY · Traditional | Orthomedics | 03/13/1981SE |
| K801712 | Lumbosacral Supports & Thoraco-Lumbo-SacIPY · Traditional | Fred Sammons, Inc. | 08/07/1980SE |
| K792269 | Wright Dow Corning Softgoods W/DowIPY · Traditional | Dow Corning Wright | 02/05/1980SE |
| K791314 | Vertebrace Spinal SupportsIPY · Traditional | Vertebrace, Inc. | 07/30/1979SE |
More from Vertebrace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K832742 | Extension Control Knee OrthosisITM · Traditional | 09/20/1983SE |
| K832741 | Jason Cervical OrthosisIQF · Traditional | 09/20/1983SE |
| K832740 | Femoral Fracture Orthosis · Traditional | 09/20/1983SE |
| K811456 | Ortho-Frac KitIQI · Traditional | 06/12/1981SE |
| K811298 | Executive CollarIQK · Traditional | 05/27/1981SE |
| K811297 | Cervical SupportIQF · Traditional | 05/27/1981SE |
| K810557 | Hip Abduction SplintIOZ · Traditional | 03/13/1981SE |
| K810556 | Spinal Extension BraceIPY · Traditional | 03/13/1981SE |
| K810555 | Scoliosis Orthotic SystemIQF · Traditional | 03/13/1981SE |
| K810554 | Lumbar Flexion BraceIPY · Traditional | 03/13/1981SE |
Questions and answers
When was Crusader Hyperextension Brace cleared by the FDA?
Crusader Hyperextension Brace (K803033) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 21 days after the submission was received.
What is the product code of K803033?
The FDA product code is IPY – Orthosis, Lumbo-Sacral, a Class I (low risk) device regulated under 21 CFR 890.3490.