510(k) K240086
- Device
- Ion 3D
- Applicant
- SurGenTec, LLC
- 510(k) number
- K240086
- Product code
- MRW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-08
- Date received
- 2024-01-11
- Classification name
- System, Facet Screw Spinal Device
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Guilherme Pires
- Address
- 911 Clint Moore Rd. Boca Raton FL US 33487 33487
FDA Registration Numbers#
- 1423662
- 3000203391
- 3016778562
- 3010047454
- 3018094310
- 3010331645
- 3010863450
- 1043653
- 3003678543
- 3008868758
- 3014725904
- 3010097171
- 3031232974
- 2031966
- 3009144915
- 1824199
- 8043792
- 3014680795
- 1057425
- 1526439
- 3004024955
- 3000170817
- 3007385214
- 1528646
- 3009888740
- 3015231789
- 3003761012
- 3008583793
- 3009882675
- 3005819474
- 3017528621
- 3006172536
- 3005031160
- 3000270450
- 1422634
- 3004188066
- 2647346
- 3003639920
- 2183946
- 3015831087
- 2953359
- 3012120772
- 3012495575
- 3013055499
- 3010162973
- 3023852420
- 2135156
- 1526534
- 3009504230
- 3019837678
- 3010120104
- 1220246
- 3006791286
- 3009732568
- 3007922509
- 2027062
- 3019878714
- 2134285
- 9617544
- 1834379
- 3012447612
- 3003477135
- 3009941480
- 1030489
- 3013548554
- 1000200989
- 2530808
- 1424263
- 3009998573
- 3004893332
- 3010462278
- 3005706667
- 3008114965
- 2954750
- 3006404071
- 3009554293
- 3030412764
- 2027467
- 3004788213
- 1833920
Source Documents#
Other 510(k) Records For Product Code MRW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | 2026-05-14 |
| K253432 | DiversiVy™ Facet Screw System | Vy Spine, LLC | 2026-03-19 |
| K251714 | Ion-C | SurGenTec, LLC | 2026-01-16 |
| K250679 | FFX Facet Fixation System | Sc Medica | 2025-12-04 |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-11-20 |
| K252153 | FFX Facet Fixation System | Sc Medica | 2025-10-16 |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-07-10 |
| K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025-05-22 |
| K242527 | The Karma® Fixation System | Spinal Elements, Inc. | 2025-05-21 |
| K243865 | AERO MIS Facet Fusion System | Aurora Spine | 2025-03-24 |
| K243265 | Ion 3D | SurGenTec, LLC | 2024-12-04 |
| K242650 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024-09-20 |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024-06-25 |
| K241416 | Ion 3D | SurGenTec, LLC | 2024-06-17 |
| K232468 | SC Medica FFX | Sc Medica | 2024-05-09 |