HA Minuteman G3-R MIS Fusion Plate
FDA 510(k) clearance K163428 · decided 2017-02-02
Clearance details
- K-number
- K163428
- Device name
- HA Minuteman G3-R MIS Fusion Plate
- Applicant
- Spinal Simplicity
- Decision
- Substantially Equivalent
- Date received
- 2016-12-06
- Decision date
- 2017-02-02
- Days to decision
- 58 days
- Clearance type
- Special
- Product code
- PEK
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Overland Park, KS, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Minuteman® G6 MIS Fusion Plate (K253250) | Spinal Simplicity, LLC | 2025-12-01 |
| Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 (K234051) | Spinal Simplicity, LLC | 2024-01-18 |
| Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate (K233527) | Spinal Simplicity, LLC | 2023-11-29 |
| KeyLift™ Expandable Interlaminar Stabilization System (K232484) | Amplio Spine, LLC | 2023-10-19 |
| primaLOK™ SP Interspinous Fusion System (K231807) | Wenzel Spine, Inc. | 2023-08-15 |
| Huvex Interspinous Fusion System (K223790) | Dio Medical Corp. | 2023-03-09 |
| Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 (K221023) | Spinal Simplicity, LLC | 2022-08-19 |
| ZIP™ MIS Interspinous Fusion System (K221399) | Aurora Spine, Inc. | 2022-07-08 |
| Minuteman G5 MIS Fusion Plate (K211880) | Spinal Simplicity, LLC | 2022-03-11 |
| Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (K212781) | Spinal Simplicity, LLC | 2021-12-15 |
| Inspan ScrewLES Fusion System (K213266) | Lespine Innovations, LLC | 2021-12-03 |
| Posterior Fusion Plate, HA Posterior Fusion Plate (K200066) | Spinal Simplicity, LLC | 2020-12-10 |
Recalls involving this device
No recalls on record reference this clearance.