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 |
|---|---|---|---|
| Sep 25, 2009 | K092631 | MANTIS REDUX SPINAL SYSTEM Stryker Spine | NKB |
| Sep 25, 2009 | K092626 | MODIFICATION TO: EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Sep 25, 2009 | K092624 | FIREBIRD SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | NKB |
| Sep 24, 2009 | K092610 | MODIFICATION TO BEACON STABILIZATION SYSTEM Globus Medical, Inc. | NKB |
| Sep 2, 2009 | K091974 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | NKB |
| Aug 14, 2009 | K090740 | MODIFICATION TO: TSRH SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Aug 13, 2009 | K091782 | REVERE 6.35 STABILIZATION SYSTEM Globus Medical, Inc. | NKB |
| Aug 7, 2009 | K092073 | MONOPOLY PEDICLE SCREW SYSTEM Signus Medical | NKB |
| Aug 7, 2009 | K091995 | LAGUNA SIZE 8 PEDICLE SCREW SYSTEM Allez Spine, LLC | NKB |
| Jul 31, 2009 | K070385 | TI-TAMED SPINAL SYSTEM Ti-Tamed (Pty), Ltd., ZA | NKB |
| Jul 30, 2009 | K090203 | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS Ebi, L.P. | NKB |
| Jul 22, 2009 | K091502 | NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. | NKB |
| Jul 22, 2009 | K090320 | CONQUEST SPINAL SYSTEM Life Spine | NKB |
| Jul 15, 2009 | K091442 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Jul 14, 2009 | K091067 | 5.5 POLARIS SPINAL SYSTEM Biomet Spine | NKB |
| Jul 9, 2009 | K091219 | DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC | NKB |
| Jul 2, 2009 | K090981 | MODIFICATION TO: NUVASIVE SPHERX SYSTEM Nuvasive, Inc. | NKB |
| Jul 2, 2009 | K083004 | MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM Aesculap Implant Systems, Inc. | NKB |
| Jul 1, 2009 | K091587 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Jul 1, 2009 | K090523 | POLARIS SPINAL SYSTEM Ebi, L.P. | NKB |
| Jun 24, 2009 | K091291 | XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD Stryker Spine | NKB |
| Jun 19, 2009 | K090099 | DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NKB |
| Jun 10, 2009 | K091266 | THEKEN CORAL SPINAL SYSTEM Theken Spine, LLC | NKB |
| Jun 10, 2009 | K090648 | VIPER 2 SYSTEM Depuy Spine, Inc. | NKB |
| May 15, 2009 | K090390 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Apr 22, 2009 | K090799 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Apr 20, 2009 | K090657 | MODIFICATION TO: S4 SPINAL SYSTEM Aesculap Implant Systems | NKB |
| Apr 1, 2009 | K083393 | XIA 3 SPINAL SYSTEM Stryker Spine | NKB |
| Mar 20, 2009 | K090408 | MODIFICATION TO: DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NKB |
| Mar 19, 2009 | K083825 | EOI SPINAL SYSTEM Expanding Orthopedics, Inc. | NKB |
| Mar 6, 2009 | K090230 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Jan 22, 2009 | K082353 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Jan 13, 2009 | K083089 | NEWPORT SPINAL SYSTEM Seaspine, Inc. | NKB |
| Jan 9, 2009 | K083416 | REVOLVE STABILIZATION SYSTEM Globus Medical, Inc. | NKB |
| Dec 11, 2008 | K082914 | CLAMPFIX Synthes Spine | NKB |
| Dec 3, 2008 | K083230 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Nov 24, 2008 | K082572 | USS ILIOSACRAL, USS POLYAXIAL Synthes Spine | NKB |
| Nov 21, 2008 | K081080 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Nov 13, 2008 | K083028 | MODIFICATION TO: NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. | NKB |
| Oct 31, 2008 | K082942 | MODFICATION TO: EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Oct 17, 2008 | K082797 | BLACKSTONE PEDICLE SCREW SYSTEM Blackstone Medical, Inc. | NKB |
| Oct 10, 2008 | K082332 | NUVASIVE SPHERX SYSTEM Nuvasive, Inc. | NKB |
| Oct 10, 2008 | K082236 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Oct 8, 2008 | K082592 | LDR SPINE EASYSPINE SYSTEM Ldr Spine USA | NKB |
| Oct 7, 2008 | K082608 | RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 Stryker Spine | NKB |
| Oct 7, 2008 | K081952 | SYNERGY SPINAL SYSTEM (6.35 POLARIS) Biomet Spine | NKB |
| Oct 6, 2008 | K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) Abbott Spine, Inc. | NKB |
| Sep 15, 2008 | K081684 | BLACKSTONE PEDICLE SCREW SYSTEM Blackstone Medical, Inc. | NKB |
| Sep 10, 2008 | K081898 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Sep 3, 2008 | K082195 | MODIFICATIONS TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
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