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 |
|---|---|---|---|
| Apr 25, 2012 | K112611 | SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS Sintea Plastek, LLC | MNI |
| Apr 13, 2012 | K120292 | CAPLOX II PEDICLE SCREW SYSTEM Captiva Spine, Inc. | MNI |
| Apr 4, 2012 | K120656 | EVEREST SPINAL SYSTEM K2m, Inc. | MNI |
| Apr 2, 2012 | K120696 | TIGER SPINE SYSTEM Corelink, LLC | MNI |
| Mar 23, 2012 | K120538 | PALLS M SPINAL SYSTEM Korea Bone Bank Co., Ltd. | MNI |
| Mar 13, 2012 | K113157 | AILERON INTERSPINOUS FIXATION SYSTEM Life Spine | MNI |
| Feb 1, 2012 | K113755 | SAVANNAH TECHNOLOGIES SPINAL SYSTEM Savannah Technologies, LLC | MNI |
| Feb 1, 2012 | K113149 | SYNTHES USS CONNECTORS Synthes Spine | MNI |
| Jan 20, 2012 | K110896 | RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems, LLC | MNI |
| Dec 21, 2011 | K112920 | RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. | MNI |
| Nov 22, 2011 | K112484 | ZAVATION SPINAL SYSTEM Zavation, LLC | MNI |
| Nov 21, 2011 | K112493 | PASS LP SPINAL SYSTEM Medicrea International | MNI |
| Oct 18, 2011 | K111883 | SMARTLOC SPINAL FIXATION SYSTEM A-Spine Asia, Co., Ltd., TW | MNI |
| Oct 6, 2011 | K112037 | RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. | MNI |
| Sep 13, 2011 | K111115 | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM Captiva Spine, Inc. | MNI |
| Aug 31, 2011 | K111913 | CAPSURE(R) PS SYSTEM Spine Wave, Inc. | MNI |
| Aug 19, 2011 | K112108 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNI |
| Aug 11, 2011 | K111127 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNI |
| Aug 2, 2011 | K110991 | MESA SPINAL SYSTEM (KEYSTONE RODS) K2m, Inc. | MNI |
| Jul 22, 2011 | K103414 | VENUS CERVICAL SPINAL FIXATION SYSTEM L&K BIOMED Co., Ltd., KR | MNI |
| Jul 15, 2011 | K110197 | EXACTECH GIBRALT SPINAL SYSTEM Exactech, Inc. | MNI |
| Jun 8, 2011 | K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM Medyssey Co, Ltd. | MNI |
| May 19, 2011 | K110283 | ZENIUS SPINAL SYSTEM Medyssey Co, Ltd. | MNI |
| Mar 17, 2011 | K103440 | EVEREST SPINAL SYSTEM K2m, Inc. | MNI |
| Feb 8, 2011 | K103102 | LEUCADIA PEDICLE SCREW SYSTEM Phygen, LLC | MNI |
| Feb 2, 2011 | K102995 | TALON SPINAL SYSTEM Spine360 | MNI |
| Dec 29, 2010 | K103272 | ZENIUS SPINAL SYSTEM Medyssey Co, Ltd. | MNI |
| Dec 16, 2010 | K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM Medyssey Co, Ltd. | MNI |
| Dec 7, 2010 | K101682 | S 100 PEDICLE SCREW SYSTEM Renovis Surgical Technologies, LLC | MNI |
| Nov 17, 2010 | K103100 | MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. | MNI |
| Nov 5, 2010 | K100407 | LIFE SPINE INTERSPINOUS FIXATION SYSTEM Life Spine | MNI |
| Oct 15, 2010 | K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM Ldr Spine USA | MNI |
| Oct 15, 2010 | K093833 | KAPSS SPINAL SYSTEM Robert Reid, Inc. | MNI |
| Aug 2, 2010 | K100851 | RANGE SPINAL SYSTEM K2m, Inc. | MNI |
| Jul 19, 2010 | K100765 | FIXPINE II SYSTEM Dio Medical Co., Ltd. | MNI |
| Jun 25, 2010 | K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM Medyssey Co, Ltd. | MNI |
| Apr 22, 2010 | K100377 | DIAMONDBACK SPINAL SYSTEM Eminent Spine | MNI |
| Apr 2, 2010 | K092076 | AEGIS & AEGIS II SPINAL SYSTEM Corentec Co., Ltd. | MNI |
| Mar 31, 2010 | K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM Ldr Spine USA | MNI |
| Mar 11, 2010 | K093936 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNI |
| Mar 4, 2010 | K100297 | PASS LP SPINAL SYSTEM Medicrea Technologies | MNI |
| Feb 17, 2010 | K100138 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. | MNI |
| Dec 23, 2009 | K093077 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. | MNI |
| Dec 10, 2009 | K093285 | MODIFICATION TO LANX SPINAL FIXATION SYSTEM Lanx, LLC | MNI |
| Nov 19, 2009 | K092420 | KRD1 PEDICLE SCREW SYSTEM Spinefrontier, Inc. | MNI |
| Nov 6, 2009 | K092640 | CASPIAN SPINAL SYSTEM K2m, Inc. | MNI |
| Nov 4, 2009 | K093170 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNI |
| Sep 14, 2009 | K092128 | MODIFICATION TO: PSS SYSTEM Spinal USA | MNI |
| Jul 31, 2009 | K083810 | PASS LP SPINAL SYSTEM Medicrea Technologies | MNI |
| Jul 8, 2009 | K091189 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. | MNI |
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