DeGen Navigated Instrumentation
510(k) K213918
DeGen Navigated Instrumentation is a Class II device made by Degen Medical, cleared under FDA 510(k) K213918 on 9 Feb 2022, 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 | NumberK213918 | Date9 Feb 2022 | StatusActive |
Official records
- FDA 510(k) database K213918
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K213918
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 | |||
|---|---|---|---|---|
| DeGen Navigated Instrumentation 15-12PC | 15-12PC / 15-12PC | 00842048144939 | Length 195.8 mm | On the market |
| DeGen Navigated Instrumentation 15-12PS | 15-12PS / 15-12PS | 00842048144946 | Length 195.8 mm | On the market |
| DeGen Navigated Instrumentation 15-22PC | 15-22PC / 15-22PC | 00842048144953 | Length 195.8 mm | On the market |
| DeGen Navigated Instrumentation 15-22PS | 15-22PS / 15-22PS | 00842048144960 | Length 195.8 mm | On the market |
| DeGen Navigated Instrumentation 15-24PC | 15-24PC / 15-24PC | 00842048155348 | — | On the market |
| DeGen Navigated Instrumentation 15-24PS | 15-24PS / 15-24PS | 00842048155355 | — | On the market |
| DeGen Navigated Instrumentation 15-25PC | 15-25PC / 15-25PC | 00842048187462 | — | On the market |
| DeGen Navigated Instrumentation 15-25PS | 15-25PS / 15-25PS | 00842048187479 | — | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
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- ORTHOMAP 3D 1.1 MODULE by Stryker Corp.
- iFuse Implant System - iFuse Navigation by Si-Bone Inc.
- DASH HIP by Brainlab AG
- Mako Total Knee Application by MAKO Surgical Corp.