Panels › Orthopedic › Product code NKB · Class 2
Thoracolumbosacral Pedicle Screw System
Regulation 888.3070
33510(k)s in 12 months (914 all time)
4recalls in 12 months (182 all time)
177recalls that name a 510(k)
Top companies in NKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 98 | 2 |
| Depuy Spine, Inc. | 30 | 10 |
| Nuvasive, Inc. | 9 | 31 |
| Spinal Elements, Inc. | 11 | 22 |
| Stryker Spine | 22 | 5 |
| Alphatec Spine, Inc. | 20 | 5 |
| Zimmer Biomet, Inc. | 0 | 25 |
| Globus Medical, Inc. | 24 | 0 |
| Life Spine | 22 | 0 |
| K2m | 20 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2017 | K173126 | Arisstos Spinal System Ingenium Spine | NKB |
| Nov 30, 2017 | K173522 | Solanas® Posterior Stabilization System Alphatec Spine, Inc. | NKB |
| Nov 30, 2017 | K172469 | TiLock Modular Spinal System Genesys Spine | NKB |
| Oct 25, 2017 | K173095 | VIPER PRIME Screws, VIPER PRIME Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations Medos International SARL, CH | NKB |
| Oct 25, 2017 | K172808 | CosmoLock Pedicle Screw System Kalitec Direct, LLC | NKB |
| Oct 23, 2017 | K172546 | AnyPlus® Spinal Fixation System GS Medical Co., Ltd., KR | NKB |
| Oct 10, 2017 | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory Stryker Corporation | NKB |
| Sep 28, 2017 | K171894 | NuVasive® Precept Spinal System Nu Vasive, Incorporated | NKB |
| Sep 27, 2017 | K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System Zimmer Biomet Spine, Inc. | NKB |
| Sep 26, 2017 | K172101 | ROMEO® 2 Posterior Osteosynthesis System Spineart, CH | NKB |
| Sep 14, 2017 | K171832 | Range/Denali/Mesa Spinal System K2m, Inc. | NKB |
| Sep 12, 2017 | K171582 | NEO Pedicle Screw System Neo Medical SA, CH | NKB |
| Aug 31, 2017 | K171570 | Additional VIPER PRIME screws with fenestrations Medos International SARL, CH | NKB |
| Aug 21, 2017 | K172107 | Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Pali Spineology, Inc. | NKB |
| Aug 21, 2017 | K171526 | Zenius, lliad and Kora Spinal Fixation Systems Medyssey USA, Inc. | NKB |
| Aug 16, 2017 | K172175 | CapSure® PS System Spine Wave, Inc. | NKB |
| Aug 11, 2017 | K161225 | Paonan Armstrong Posterior Spinal Fixation System Paonan Biotech Co., Ltd., TW | NKB |
| Aug 4, 2017 | K170861 | Premier Shandong Weigao Orthopaedic Device Co., Ltd., CN | NKB |
| Aug 3, 2017 | K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems Choicespine | NKB |
| Aug 1, 2017 | K171758 | M.U.S.T. Combined Set Screws Medacta International S.A., CH | NKB |
| Jul 24, 2017 | K171559 | True Spinal Fixation System Innovative Surgical Designs, Inc. | NKB |
| Jul 19, 2017 | K171838 | TiLock2 Spinal System Genesys Spine | NKB |
| Jul 14, 2017 | K171907 | Vitality® Spinal Fixation System Zimmer Biomet Spine, Inc. | NKB |
| Jul 14, 2017 | K170710 | True Spinal Fixation System Innovative Surgical Designs, Inc. | NKB |
| Jul 13, 2017 | K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Jun 29, 2017 | K163011 | PHA S1 Spinal System Phamedica, Inc. | NKB |
| Jun 26, 2017 | K170045 | Swedge Pedicle Screw Fixation System Spinal Resources, Inc. | NKB |
| Jun 12, 2017 | K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System Medyssey USA, Inc. | NKB |
| Jun 8, 2017 | K170821 | ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System Choicespine, LP | NKB |
| Jun 2, 2017 | K171438 | Palisade Pedicular Fixation System Spineology, Inc. | NKB |
| May 25, 2017 | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws Medacta International S.A., CH | NKB |
| May 25, 2017 | K170611 | SETx Pedicle Screw System Xenco Medical, LLC | NKB |
| May 22, 2017 | K170989 | Dymaxeon Spine System Back 2 Basics Direct, LLC | NKB |
| May 16, 2017 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory Stryker Corporation | NKB |
| May 11, 2017 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated R Medtronic Sofamor Danek | NKB |
| May 5, 2017 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spina Orthofix, Inc. | NKB |
| May 4, 2017 | K170543 | VIPER PRIME Screws with Fenestrations Medos International SARL, CH | NKB |
| May 2, 2017 | K170108 | Xultan 5.5 Pedicle Screw System Met One Technologies | NKB |
| Apr 26, 2017 | K170964 | Zenius Spinal System Medyssey USA, Inc. | NKB |
| Apr 26, 2017 | K170942 | The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems Choicespine, LP | NKB |
| Apr 14, 2017 | K170268 | Fortress Pedicular Fixation System Spineology, Inc. | NKB |
| Apr 14, 2017 | K170266 | Palisade Pedicular Fixation System Spineology, Inc. | NKB |
| Apr 14, 2017 | K170255 | Threshold V2 Pedicular Fixation System Spineology, Inc. | NKB |
| Apr 14, 2017 | K170251 | Threshold Pedicular Fixation System Spineology, Inc. | NKB |
| Apr 5, 2017 | K163363 | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System Surgtech, Inc. | NKB |
| Apr 4, 2017 | K170347 | CD HORIZON Fenestrated Screw Set Medtronic Sofamor Danek USA | NKB |
| Mar 31, 2017 | K163096 | GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System Gpc Medical Limited, IN | NKB |
| Mar 30, 2017 | K162995 | Ibis® Pedicle Screw System Ortho Development Corporation | NKB |
| Mar 29, 2017 | K170654 | USS System Synthes USA Products, LLC | NKB |
| Mar 9, 2017 | K170528 | Sterispine PS Safe Orthopaedics, FR | NKB |
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