Lever Action Plate System 0
by Mcginley Orthopaedic Innovations, Inc 111 variants
Lever Action Plate System 0 (MCG-B21) is a Class II device made by Mcginley Orthopaedic Innovations, Inc, cleared under FDA 510(k) K200834 on 25 Jun 2020 and listed in FDA GUDID since 8 Jul 2024 (UDI-DI B666MCGB210), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB666MCGB210 | Date8 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200834 | Date25 Jun 2020 | StatusActive |
Official records
- FDA 510(k) database K200834
Across registries
- FDA 510(k) K200834 decided 25 Jun 2020 Active
- FDA GUDID UDI-DI B666MCGB210 listed 8 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K200834
- Listed FDA GUDID B666MCGB210
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lever Action Plate System
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- 0, MCG-B21
- Primary DI / UDI-DI
- B666MCGB210
- 510(k) Number
- FDA product code
- HRS
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
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