Kimba Mini
510(k) K080349
Kimba Mini is a Class II device made by SIGNUS Medizintechnik GmbH, cleared under FDA 510(k) K080349 on 10 Mar 2008, 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 | NumberK080349 | Date10 Mar 2008 | StatusActive |
Official records
- FDA 510(k) database K080349
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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