DeGen Impulse AM™ System
510(k) K223418
DeGen Impulse AM™ System is a Class II device made by Degen Medical, cleared under FDA 510(k) K223418 on 17 Mar 2023, active as of 26 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 | NumberK223418 | Date17 Mar 2023 | StatusActive |
Official records
- FDA 510(k) database K223418
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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