GYDER® Hip System
510(k) K243387
GYDER Hip System is a medical device (FDA Class II; FDA product code OLO, Orthopedic Stereotaxic Instrument) made by Gyder Surgical Pty Ltd, cleared under FDA 510(k) K243387 on 29 Jan 2025, 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 | NumberK243387 | Date29 Jan 2025 | StatusActive |
Official records
- FDA 510(k) database K243387
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- FDA applicant
- Gyder Surgical Pty, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K243387
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 | |||
|---|---|---|---|---|
| Navigation Toolset GS005 | GS005 | 09360506000128 | On the market | |
| Navigation Unit Kit GS004 | GS004 | 09360506000111 | On the market | |
| Single Use Kit GS002 | GS002 | 09360506000029 | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
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- RENAISSANCE X SYSTEM by MAZOR ROBOTICS LTD
- Naviswiss Hip Navigation System by Naviswiss AG
- Integrity Implants Navigated Instruments by Integrity Implants Inc.
- 9734563 by Medtronic Navigation Inc.