Panels › Orthopedic › Product code MNI · Class 2
Orthosis, Spinal Pedicle Fixation
Regulation 888.3070
0510(k)s in 12 months (303 all time)
1recalls in 12 months (213 all time)
212recalls that name a 510(k)
Top companies in MNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Valorem Surgical LLC | 0 | 144 |
| Allez Spine, LLC | 1 | 27 |
| Medtronic Sofamor Danek | 25 | 0 |
| K2m, Inc. | 15 | 0 |
| Spine Wave, Inc. | 11 | 0 |
| Blackstone Medical, Inc. | 7 | 3 |
| Stryker Spine | 7 | 2 |
| Spinal USA | 8 | 0 |
| Spinal Solutions, LLC | 0 | 8 |
| Life Spine | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2009 | K090779 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. | MNI |
| Jun 30, 2009 | K090984 | INERTIA PEDICLE SCREW SYSTEM Nexxt Spine, LLC | MNI |
| May 6, 2009 | K090033 | MODIFICATION TO: PSS SYSTEM Spinal USA | MNI |
| Mar 27, 2009 | K083863 | THEKEN ATOLL OCT SPINAL SYSTEM Theken Spine, LLC | MNI |
| Mar 26, 2009 | K081978 | RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems, LLC | MNI |
| Mar 13, 2009 | K083073 | THEKEN ATOLL CERVICO-THORACIC SYSTEM Theken Spine, LLC | MNI |
| Feb 23, 2009 | K083178 | SOLAS ANATOMIX SPINAL SYSTEM Biotechni America Spine Group, Inc. | MNI |
| Jan 28, 2009 | K083865 | PILOT SPINAL SYSTEM Life Spine | MNI |
| Jan 15, 2009 | K082617 | TRAUSON GENERAL SPINAL SYSTEM (GSS) Trauson (Jiangsu) Medical Instrument Co., Ltd., CN | MNI |
| Jan 13, 2009 | K083743 | CAPSURE PS SYSTEM Spine Wave, Inc. | MNI |
| Dec 11, 2008 | K083353 | CAPSURE(R) PS SYSTEM Spine Wave, Inc. | MNI |
| Dec 10, 2008 | K083308 | PASS LP SPINAL SYSTEM Medicrea Technologies | MNI |
| Nov 5, 2008 | K081145 | MODIFICATION TO 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNI |
| Oct 3, 2008 | K082069 | PASS 2 SPINAL SYSTEM Medicrea Technologies | MNI |
| Jul 24, 2008 | K081790 | MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM Trinity Orthopedics, LLC | MNI |
| Jul 23, 2008 | K080841 | COSMIC SYSTEM Ulrich GmbH & Co. KG | MNI |
| Jul 3, 2008 | K081158 | ZODIC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. | MNI |
| Jul 2, 2008 | K081597 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM Vertebron, Inc. | MNI |
| Jul 2, 2008 | K071668 | ORTHOBIOM SPINAL SYSTEM Paradigm Spine | MNI |
| Jul 2, 2008 | K071074 | MYKRES SPINAL SYSTEM Showa Ika Kohgyo Co., Ltd. | MNI |
| May 21, 2008 | K080767 | CONQUEST SPINAL SYSTEM Life Spine | MNI |
| May 12, 2008 | K081228 | CAPSURE PS (R) SPINE SYSTEM Spine Wave, Inc. | MNI |
| Apr 9, 2008 | K080099 | PASS SPINAL SYSTEM Medicrea Technologies | MNI |
| Apr 8, 2008 | K080792 | K2M COCR ROD K2m, Inc. | MNI |
| Apr 8, 2008 | K080502 | MODIFICATION TO:PILOT SPINAL SYSTEM Life Spine | MNI |
| Apr 7, 2008 | K073143 | MODIFIED VERTIFLEX SPINAL SCREW SYSTEM Vertiflex, Inc. | MNI |
| Mar 20, 2008 | K073240 | PSS SYSTEM Spinal USA | MNI |
| Mar 13, 2008 | K080407 | BLACKSTONE SFS PARALLEL ROD CONNECTORS Blackstone Medical, Inc. | MNI |
| Feb 14, 2008 | K080143 | MODIFICATION TO STRYKER SPINE OASYS SYSTEM Stryker Spine | MNI |
| Jan 28, 2008 | K080075 | MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM Elite Surgical Supplies (Pty), Ltd. | MNI |
| Jan 28, 2008 | K080026 | QUANTUM-MIS CANNULATED SYSTEM Pioneer Surgical Technology | MNI |
| Jan 10, 2008 | K072434 | SYNTHES OC FUSION AND SYNAPSE SYSTEMS Synthes Spine Co.Lp | MNI |
| Jan 3, 2008 | K072914 | NATURAL BRIDGE LP TRANSVERSE CONNECTORS K2m, Inc. | MNI |
| Nov 1, 2007 | K072436 | MEGA SPINE SYSTEM Bk Meditech, Co., Ltd. | MNI |
| Oct 12, 2007 | K072187 | PIONEER LOWTOP SPINAL ROD SYSTEM Pioneer Surgical Technology | MNI |
| Oct 5, 2007 | K071880 | Optima ZS Transition Screw Zimmer Spine, Inc. | MNI |
| Sep 21, 2007 | K070276 | MODIFICATION TO PASSMED SPINAL SYSTEM Medicrea Technologies | MNI |
| Sep 17, 2007 | K071877 | LANX SPINAL FIXATION SYSTEM Lanx, LLC | MNI |
| Sep 4, 2007 | K071824 | ACME TALON PEDICLE SCREW Acme Spine, LLC | MNI |
| Aug 30, 2007 | K063453 | VERTEFIX PEDICLE SCREW SPINAL SYSTEM Elite Surgical Supplies (Pty), Ltd. | MNI |
| Aug 21, 2007 | K071438 | PSS SYSTEM Spinal USA | MNI |
| Aug 8, 2007 | K071857 | DELTA SPINAL FUSION SYSTEM Jemo Spine, LLC | MNI |
| Aug 6, 2007 | K071435 | NUVASIVE OCT SYSTEM Nuvasive, Inc. | MNI |
| Jul 6, 2007 | K071743 | PILLAR PEDICLE SCREW SYSTEM The 4th Column, LLC | MNI |
| Jun 8, 2007 | K070573 | SYNAPSE SYSTEM Synthes Spine Co.Lp | MNI |
| May 21, 2007 | K070295 | SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM Trinity Orthopedics, LLC | MNI |
| May 18, 2007 | K063668 | ROC LUMBAR SYSTEM Alphatec Spine, Inc. | MNI |
| May 3, 2007 | K070229 | RANGE SPINAL SYSTEM K2m, Inc. | MNI |
| Apr 24, 2007 | K063708 | 4S SPINAL SYSTEM Taeyeon Medical Co., Ltd., KR | MNI |
| Apr 5, 2007 | K070245 | CAPSURE PEDICLE SCREW SYSTEM Spine Wave, Inc. | MNI |
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