Cylinder Knee Cast/Splint
FDA 510(k) K811689 · Surgical Appliance Industries, Inc.
510(k) numberK811689
Submission
- Device name
- Cylinder Knee Cast/Splint
- Applicant
- Surgical Appliance Industries, Inc.
Walker, MI, US - Received
- June 15, 1981
- Decision date
- June 25, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITQ – Joint, Knee, External Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ITQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831044 | Limited Motion Functional Knee BraceITQ · Traditional | Orthopedic Systems, Inc. | 06/24/1983SE |
| K831310 | Brace C.T.ITQ · Traditional | Innovation Sports, Inc. | 05/16/1983SE |
| K823658 | Deluxe Knee Immobilizer(Universal)ITQ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823397 | Anatomic Fracture BraceITQ · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K823159 | Deluxe Knee ImmobilizerITQ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | Aircast, Inc. | 08/13/1981SE |
| K810222 | Limb OrhtosisITQ · Traditional | Medical Design & Manufacturing Corp. | 02/04/1981SE |
| K802673 | Knee Brace/StabilizerITQ · Traditional | Omni Scientific, Inc. | 11/12/1980SE |
| K780892 | Fracture BracingITQ · Traditional | Hosmer Dorrance Corp. | 06/13/1978SE |
More from Hosmer Dorrance Corp.
| 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 |
| K812401 | Cruciform Anterior Spinal Hyperexten. OIPT · Traditional | 09/14/1981SE |
| K811690 | Ankle-Foot Cast/SplintIQI · Traditional | 06/25/1981SE |
| K811494 | Lumbo-Sacral Flexion OrthosisIPY · Traditional | 06/16/1981SE |
Questions and answers
When was Cylinder Knee Cast/Splint cleared by the FDA?
Cylinder Knee Cast/Splint (K811689) received a 510(k) decision of Substantially Equivalent on June 25, 1981, 10 days after the submission was received.
What is the product code of K811689?
The FDA product code is ITQ – Joint, Knee, External Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.