FDA Product Code
FDA Product Code NKG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3075
510(k) Clearances — 119 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153386 | Perla Posterior Cervico-Thoracic Fixation system | Spineart | 2016-01-25 | Traditional | PDF ↗ |
| K153336 | VuePoint OCT System | Nu Vasive, Incorporated | 2016-01-07 | Traditional | PDF ↗ |
| K152211 | PCT System | Centinel Spine, Inc. | 2015-12-01 | Traditional | PDF ↗ |
| K152338 | VERTEX(r) Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015-10-28 | Traditional | PDF ↗ |
| K151938 | S4 Cervical Spinal and Occiput Systems | Aesculap Implant Systems, LLC | 2015-10-21 | Traditional | PDF ↗ |
| K150474 | NuVasive VuePoint II OCT System | Nu Vasive, Incorporated | 2015-10-21 | Traditional | PDF ↗ |
| K150918 | PASS OCT Spinal System | Medicrea International SA | 2015-10-16 | Traditional | PDF ↗ |
| K150650 | neon3 | Ulrich GmbH & Co. KG | 2015-09-24 | Traditional | PDF ↗ |
| K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | Depuy Synthes, Inc. | 2015-09-03 | Traditional | PDF ↗ |
| K151705 | Lotus Posterior Cervical/Thoracic Spinal System | Spinal Elements, Inc. | 2015-09-03 | Traditional | PDF ↗ |
| K151755 | OASYS(r) System | Stryker Corporation | 2015-07-09 | Traditional | PDF ↗ |
| K151224 | Lineum OCT Spine System | Biomet Spine | 2015-06-30 | Traditional | PDF ↗ |
| K151031 | Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | 2015-06-24 | Traditional | PDF ↗ |
| K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015-06-04 | Traditional | PDF ↗ |
| K150570 | ANAX OCT Spinal System | U&I Corporation | 2015-06-03 | Traditional | PDF ↗ |
| K150822 | Centurion POCT System | Orthofix, Inc. | 2015-05-15 | Traditional | PDF ↗ |
| K150539 | OASYS System | Stryker Corporation | 2015-05-12 | Traditional | PDF ↗ |
| K143471 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015-02-06 | Traditional | PDF ↗ |
| K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015-01-20 | Traditional | PDF ↗ |
Product code NKG · Class II · Orthopedic. Data: openFDA.