510(k) K242516
- Device
- EUROPA? Posterior Cervical Fusion System
- Applicant
- MiRus, LLC
- 510(k) number
- K242516
- Product code
- NKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-19
- Date received
- 2024-08-23
- 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
Related Records
Applicant Contact
- Contact
- Anuradha Nagulapati
- Address
- 1755 W. Oak Pkwy. Suite 100 Marietta GA US 30062 30062
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
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|---|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | 2026-03-16 |
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| 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 |
| 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 |
| K231654 | NorthStar OCT System | Seaspine, Inc. | 2023-08-03 |