510(k) K031576
K031576 is an FDA 510(k) premarket notification submitted by Surgitech, Inc. for the device "SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1". The FDA issued a decision of Substantially Equivalent on July 31, 2003. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Surgitech, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2003
- Date Received
- May 20, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Limb Brace
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type