Cruciform Anterior Spinal Hyperexten. O
FDA 510(k) K812401 · Surgical Appliance Industries, Inc.
510(k) numberK812401
Submission
- Device name
- Cruciform Anterior Spinal Hyperexten. O
- Applicant
- Surgical Appliance Industries, Inc.
Mchenry, IL, US - Received
- August 20, 1981
- Decision date
- September 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IPT – Orthosis, Thoracic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Specialty
- Physical Medicine
Other 510(k)s with product code IPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963091 | Vollman Prone PositionerIPT · Traditional | Hill-Rom, Inc. | 01/09/1997SE |
| K821645 | Back SkpportsIPT · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K811750 | Multitubular Thoracic Air SplintsIPT · Traditional | Roger Cestac & Assoc. | 07/20/1981SE |
| K761128 | Lateral Trunk SupportsIPT · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121106 | Truform Ready-To-Wear Compression Arm Sleece Truform Ready-To-Wear Compression GauntletDWL · Traditional | 04/27/2012SE |
| K821682 | Truncal OrthosisIQE · Traditional | 06/24/1982SE |
| K813416 | External Breast ProsthesisGBI · Traditional | 01/18/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | 09/14/1981SE |
| K812422 | Custom Contour Lumbosacral OrthosisIPY · Traditional | 09/14/1981SE |
| K811690 | Ankle-Foot Cast/SplintIQI · Traditional | 06/25/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | 06/25/1981SE |
| K811494 | Lumbo-Sacral Flexion OrthosisIPY · Traditional | 06/16/1981SE |
Questions and answers
When was Cruciform Anterior Spinal Hyperexten. O cleared by the FDA?
Cruciform Anterior Spinal Hyperexten. O (K812401) received a 510(k) decision of Substantially Equivalent on September 14, 1981, 25 days after the submission was received.
What is the product code of K812401?
The FDA product code is IPT – Orthosis, Thoracic, a Class I (low risk) device regulated under 21 CFR 890.3490.