Spartan Orthopaedic Wrist Brace, Model SCT-1
FDA 510(k) K031576 · Surgitech, Inc.
510(k) numberK031576
Submission
- Device name
- Spartan Orthopaedic Wrist Brace, Model SCT-1
- Applicant
- Surgitech, Inc.
Oceanside, CA, US - Received
- May 20, 2003
- Decision date
- July 31, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
| K823160 | Rotation BootIQI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
More from Warm & Form, Orthopedic Materials
| 510(k) | Device | Decision |
|---|---|---|
| K033358 | Chronic Pain Suppressor CPS-2000, Model CPS-2000LIH · Traditional | 11/14/2003SE |
Questions and answers
When was Spartan Orthopaedic Wrist Brace, Model SCT-1 cleared by the FDA?
Spartan Orthopaedic Wrist Brace, Model SCT-1 (K031576) received a 510(k) decision of Substantially Equivalent on July 31, 2003, 72 days after the submission was received.
What is the product code of K031576?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.