HipCheck
510(k) K230045
HipCheck is a Class II device made by Stryker Corp., cleared under FDA 510(k) K230045 on 29 Sep 2023, 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 | NumberK230045 | Date29 Sep 2023 | StatusActive |
Official records
- FDA 510(k) database K230045
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K230045
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 | |||
|---|---|---|---|---|
| HipMap Femoroacetabular Impingement Analysis 3105001000 | 3105001000 / 3105001000 | 07613327382570 | — | On the market |
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