510(k) K181603
- Device
- EVEREST Spinal System, RANGE (MESA And DENALI) Spinal System, CASPIAN OCT (MESA Mini And DENALI Mini) Spinal System, YUKON OCT Spinal System
- Applicant
- K2M Inc.
- 510(k) number
- K181603
- Product code
- NKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-05
- Date received
- 2018-06-19
- 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
- Nancy Giezen
- Address
- 600 Hope Pkwy. SE Leesburg VA US 20175 20175
FDA Registration Numbers#
- 3005677016
- 3005706667
- 9617297
- 3008583793
- 3009173317
- 3004638600
- 3010123206
- 3014725904
- 3016438694
- 3012120772
- 3030412764
- 3003761012
- 3005562917
- 3009381600
- 3003477135
- 9611827
- 3009973699
- 2183449
- 3015212339
- 3010041430
- 3007922509
- 3008868758
- 1833824
- 3006846753
- 3005031160
- 1226544
- 3009959868
- 3014782362
- 3010120104
- 1000517406
- 3006783837
- 3009973336
- 3007993775
- 1527105
- 1030489
- 3006791286
- 2031966
- 3013194153
- 3010057495
- 3004893332
- 8043792
- 3005819474
- 3043520111
- 3004142400
- 3014680795
- 3000170817
- 3008285983
- 3006128100
- 1221763
- 3011795235
- 1526439
- 3011187779
- 3019837678
- 3009169872
- 3013491327
- 3043543260
- 3010032903
- 1043653
- 3006493760
- 2027467
- 3009049161
- 3010178296
- 3005739886
- 3009882675
- 9611390
- 9612420
- 3004717358
- 9611813
- 3003387384
- 3011181154
- 3008534770
- 3016084569
- 3005874553
- 1835831
- 3037407500
- 3010047454
- 3012447612
- 3004774118
- 3010531060
- 3004635447
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#
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