510(k) K150570
- Device
- ANAX OCT Spinal System
- Applicant
- U&I Corporation
- 510(k) number
- K150570
- Product code
- NKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-06-03
- Date received
- 2015-03-06
- Regulation
- 888.3075
- Classification name
- Posterior Cervical Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Young-Geun Kim
- Address
- 20, Sandan-Ro 76beon-Gil (Rd.) Uijeongbu-Si, Gyeonggi-Do KR 480859 480859
FDA Registration Numbers#
- 3007485169
- 3006128100
- 3006563559
- 2183449
- 9610612
- 3014763043
- 9615021
- 1835444
- 3013194153
- 9611813
- 2648623
- 3008110533
- 3006984710
- 3010047454
- 3009049161
- 3005562917
- 3005874553
- 3007993775
- 3012711663
- 3018094310
- 3009973505
- 3010863450
- 1833824
- 1043653
- 3008868758
- 2028632
- 3014725904
- 3006378738
- 3005823819
- 3009790163
- 3013491327
- 3008262872
- 3009144915
- 3010363503
- 1000432246
- 2031966
- 1824199
- 8043792
- 3010120148
- 3014680795
- 1526439
- 9611827
- 3004024955
- 3000170817
- 3003761012
- 3008812560
- 3008583793
- 3009882675
- 3006783837
- 3015869493
- 3005819474
- 1000461041
- 3017528621
- 3005180920
- 3005031160
- 3000270450
- 3009417901
- 3015440604
- 3014782362
- 3005677016
- 3004188066
- 2647346
- 3006493760
- 3015831087
- 2953359
- 3012120772
- 3009380063
- 9612420
- 1226544
- 3007728266
- 3016438694
- 3003661942
- 3008285983
- 1526534
- 3011187779
- 3019837678
- 3012994232
- 3010120104
- 3009504230
- 3004717358
Source Documents#
Other 510(k) Records For Product Code NKG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | 2026-03-16 |
| K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 |
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025-11-12 |
| K253129 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| K251725 | ANAX™ OCT Spinal System | Cg Medtech Co., Ltd. | 2025-06-25 |
| K250866 | Sovereign Posterior Cervical System | Met One Technologies, LLC | 2025-05-20 |
| K242674 | Freedom Posterior Cervical Screws | Signature Orthopaedics Pty, Ltd. | 2025-05-13 |
| K250332 | Virage® OCT Spinal Fixation System | Highridge Medical, LLC | 2025-04-04 |
| K242516 | EUROPA™ Posterior Cervical Fusion System | MiRus, LLC | 2024-11-19 |
| K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | 2024-03-27 |
| K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024-03-14 |
| K233332 | Statera-C™ Spinal System | K&J Consulting Corp. | 2023-11-27 |
| K233078 | Posterior Cervical Spine System | Double Medical Technology, Inc. | 2023-11-22 |
| K233366 | SYMPHONY OCT System | Medos International SARL | 2023-11-09 |
| K232167 | VySpan™ PCT System | Vy Spine, LLC | 2023-09-27 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases