510(k) K234051
- Device
- 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
- Applicant
- Spinal Simplicity, LLC
- 510(k) number
- K234051
- Product code
- PEK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-18
- Date received
- 2023-12-21
- Regulation
- 888.3050
- Classification name
- Spinous Process Plate
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Adam Rogers
- Address
- 6363 College Blvd. Suite 320 Overland Park KS US 66211 66211
FDA Registration Numbers
- 1423662
- 3016050940
- 1450662
- 2135156
- 3006217744
- 3014967969
- 3009888740
- 9611390
- 3004893332
- 3010178296
- 3012131184
- 3005144609
- 3020417298
- 2530808
- 3037407500
- 3005031160
- 3004072627
- 3033509898
- 3017565094
- 3010160527
- 3010863450
- 3019767615
- 2027062
- 3010057495
- 3036756245
- 1224360
- 3016438694
- 3009871135
- 2183744
- 3009165919
- 3006128100
- 3009973505
- 3009554293
- 3015924373
- 2032098
- 3005739886
- 1649518
- 3013055499
- 3005977257
- 3006172536
- 3005706667
- 3009882675
- 3007441485
- 3009217531
- 3025603301
- 3012447612
- 3030412764
- 3025435185
- 3016112537
- 2031093
- 3011513267
- 1530390
- 3004142400
- 3004788213
- 2031966
- 3010120148
- 3010120135
- 3013491327
- 3009704301
- 3004024955
- 1060840
- 8043792
- 3010032903
- 3012120772
- 9617297
- 3008526708
- 3010120104
- 1526534
- 3006846753
- 3005426761
- 3010326971
- 3007728266
- 2029275
- 3008583793
- 1529009
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code PEK
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253250 | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | 2025-12-01 |
| K233527 | 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 | Spinal Simplicity, LLC | 2023-11-29 |
| K232484 | KeyLift Expandable Interlaminar Stabilization System | Flospine | 2023-10-19 |
| K231807 | primaLOK SP Interspinous Fusion System | Wenzel Spine, Inc. | 2023-08-15 |
| K223790 | Huvex Interspinous Fusion System | Dio Medical Corp. | 2023-03-09 |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | Spinal Simplicity, LLC | 2022-08-19 |
| K221399 | ZIP MIS Interspinous Fusion System | Aurora Spine, Inc. | 2022-07-08 |
| K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | 2022-03-11 |
| K212781 | 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 | Spinal Simplicity, LLC | 2021-12-15 |
| K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | 2021-12-03 |
| K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020-12-10 |
| K201704 | CoFix System | Paradigm Spine GmbH | 2020-08-04 |
| K182352 | SP-LINK System | Medical Designs, LLC | 2018-11-21 |
| K180817 | AERIAL Interspinous Fixation | Globus Medical, Inc. | 2018-05-21 |
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018-03-07 |