Alta Multipurpose Device
by Qfix
510(k) K193243
Alta Multipurpose Device is a Class II device made by Qfix, cleared under FDA 510(k) K193243 on 28 Feb 2020, 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 | NumberK193243 | Date28 Feb 2020 | StatusActive |
Official records
- FDA 510(k) database K193243
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K193243
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Alta for HexaPOD RT-4800-05 | RT-4800-05 / RT-4800-05 | 00841962120456 | — | On the market |
| Alta RT-4800-02 | RT-4800-02 / RT-4800-02 | 00841962119603 | — | On the market |
| Alta RT-4800-03 | RT-4800-03 / RT-4800-03 | 00841962119597 | — | On the market |
| Alta RT-4800-GL | RT-4800-GL / RT-4800-GL | 00841962119726 | — | On the market |
| Alta RT-4800-H30 | RT-4800-H30 / RT-4800-H30 | 00841962119733 | — | On the market |
| Alta RT-4800-H45 | RT-4800-H45 / RT-4800-H45 | 00841962119740 | — | On the market |
| Alta RT-4800-SR | RT-4800-SR / RT-4800-SR | 00841962119764 | — | On the market |
| InfinityLock™ RT-4800-04 | RT-4800-04 / RT-4800-04 | 00841962119757 | — | On the market |
| InfinityLock™ RT-4800-04-DP | RT-4800-04-DP / RT-4800-04-DP | 00841962119580 | — | On the market |
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