Butterfly Plate Function System
by Medtronic Sofamor Danek USA, Inc.
510(k) K010632
Butterfly Plate Function System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K010632 on 31 May 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010632 | Date31 May 2001 | StatusActive |
Official records
- FDA 510(k) database K010632
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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