Mitchell Ponseti® Bracing System PS-SM
Mitchell Ponseti® Bracing System PS-SM is a Class I device made by MD Orthopaedics, listed in FDA GUDID since 15 Dec 2025 (UDI-DI 00810060888599), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810060888599 | Date15 Dec 2025 | StatusListed |
Official records
- AccessGUDID record 00810060888599
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Mitchell Ponseti® Bracing System
- Generic name
- Ankle/foot orthosis
- Model / reference
- PS-SM
- Primary DI / UDI-DI
- 00810060888599
- FDA product code
- KNP
- GMDN term
- Ankle/foot orthosis
- Device class
- Class I
- Regulation number
- 890.3475
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe