Humerous Fracture Brace, Ulna Fracture
FDA 510(k) K801788 · Hosmer Dorrance Corp.
510(k) numberK801788
Submission
- Device name
- Humerous Fracture Brace, Ulna Fracture
- Applicant
- Hosmer Dorrance Corp.
Mchenry, IL, US - Received
- July 29, 1980
- Decision date
- August 7, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IQI – Orthosis, Limb Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
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| K052771 | Sensor WalkIQI · Traditional | Otto Bock Healthcare LP | 05/03/2006SE |
| K031576 | Spartan Orthopaedic Wrist Brace, Model SCT-1IQI · Traditional | Surgitech, Inc. | 07/31/2003SE |
| K926391 | Accuflex Dynamic Elbow OrthosisIQI · Traditional | Regulatory & Marketing Services, Inc. | 07/22/1993SE |
| K910974 | Mcconnell Shoulder BraceIQI · Traditional | Mcconnell Orthopedic | 03/21/1991SE |
| K874502 | Gait-Aid Orthopedic InsoleIQI · Traditional | Gait-Aid, Inc. | 11/30/1987SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K831615 | Drop Foot BraceIQI · Traditional | Edward Dilauro, Jr. | 06/15/1983SE |
| K823812 | Various Supports and SplintsIQI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823113 | Brace-Up All Purpose Wrist BandIQI · Traditional | Arco Matic, Inc. | 11/16/1982SE |
More from Arco Matic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822632 | Elbow ProsthesisIRE · Traditional | 09/14/1982SE |
| K821704 | Fracture BracingIQI · Traditional | 06/24/1982SE |
| K780892 | Fracture BracingITQ · Traditional | 06/13/1978SE |
| K780891 | Post-Operative Hip OrthosisITS · Traditional | 06/13/1978SE |
| K780890 | Capp Terminal DeviceIQX · Traditional | 06/13/1978SE |
| K761314 | Flexion-Braking Knee-Shin AssemblyION · Traditional | 01/10/1977SE |
| K761313 | 4-BAR Knee-Shin Set-UpION · Traditional | 01/10/1977SE |
| K761312 | Orthotic BracingIQI · Traditional | 01/10/1977SE |
Questions and answers
When was Humerous Fracture Brace, Ulna Fracture cleared by the FDA?
Humerous Fracture Brace, Ulna Fracture (K801788) received a 510(k) decision of Substantially Equivalent on August 7, 1980, 9 days after the submission was received.
What is the product code of K801788?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.