Tiger 2 System
Zavation Medical Products, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008583793 | 3008583793 | ZAVATION | 1 | N | 2026-01-01 | 3670 Flowood Dr Flowood MS US 39232 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00197157071400 | ZAVATION ROD BENDER - INSITU BENDER - RIGHT 6.0 ROD | 6019191119 | info@zavation.com |
| 00197157071417 | ZAVATION ROD BENDER - INSITU BENDER - LEFT 6.0 ROD | 6019191119 | info@zavation.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 210005 | 1551458093 | K243908 | Tiger 2 System | NKB | 2025-02-03 |
| 210005 | 1949156932 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | MAX | 2024-04-10 |
| 210005 | 1714236833 | K231811 | Zavation Connector System | NKB | 2023-08-22 |
| 210005 | 1199097056 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | MAX | 2023-12-08 |
| 210005 | 2060307269 | K230880 | CoreLink Navigation Instruments | OLO | 2023-05-02 |
| 210005 | 1710924991 | K230731 | Zavation ALIF System | OVD | 2023-06-14 |
| 210005 | 1074210768 | K230329 | F3D Interbody System | ODP | 2023-06-06 |
| 210005 | 1522020828 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | OUR | 2023-03-21 |
| 210005 | 1651804003 | K222614 | Zavation Spinal System | NKB | 2022-12-05 |
| 210005 | 1021846131 | K221776 | NextGen Pedicle Screw System | NKB | 2022-08-09 |
| 210005 | 1663054322 | K221726 | Uni-FuZe-C Bone Strip | MQV | 2023-01-18 |
| 210005 | 1549922058 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | OVE | 2022-08-12 |
| 210005 | 1902195569 | K220973 | CoreLink Navigation Instruments | OLO | 2022-06-01 |
| 210005 | 1006248307 | K214059 | CoreLink Navigation Instruments | OLO | 2022-01-19 |
| 210005 | 1039032172 | K212825 | CoreLink Navigation Instruments | OLO | 2021-10-13 |
| 210005 | 1161599350 | K211993 | Z-LINKPC System | NKG | 2021-08-11 |
| 210005 | 1954438061 | K211417 | F3D-C2 Cervical Stand-Alone System | OVE | 2022-02-04 |
| 210005 | 1446338798 | K211306 | LABYRINTH | MAX | 2021-06-24 |
| 210005 | 2028971993 | K211113 | Zavation Spinal System | NKB | 2021-07-12 |
| 210005 | 1585437648 | K210539 | CoreLink Midline Fixation System | NKB | 2021-04-15 |
| 210005 | 2045115528 | K202637 | F3D Corpectomy System | MQP | 2020-12-23 |
| 210005 | 1685964032 | K202624 | Z-Span Plate System | KWQ | 2020-11-04 |
| 210005 | 1483923699 | K202305 | Zavation IBF System | MAX | 2020-10-13 |
| 210005 | 1867977005 | K201781 | Uni-FuZe-P Bone Putty | MQV | 2020-12-28 |
| 210005 | 1744445327 | K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | NKG | 2020-04-28 |
| 210005 | 1172100215 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | OVE | 2020-06-15 |
| 210005 | 1295171410 | K200084 | Zavation IBF System | MAX | 2020-10-19 |
| 210005 | 1699848106 | K191423 | Normandy VBR System | PLR | 2019-08-06 |
| 210005 | 2062277563 | K191354 | Ti3Z Cervical Interbody System | ODP | 2019-09-09 |
| 210005 | 1410085744 | K191339 | Zavation eZspand Interbody System | MAX | 2019-08-19 |
| 210005 | 1289107015 | K190361 | Zavation Spinal System | NKB | 2019-03-18 |
| 210005 | 1651245505 | K190317 | Zavation Spinal System | NKB | 2019-04-11 |
| 210005 | 1030783867 | K190016 | Lateral Plate System | KWQ | 2019-06-12 |
| 210005 | 1892152645 | K183239 | CoreLink F3D Lateral System | MAX | 2018-12-19 |
| 210005 | 1772381616 | K182731 | Corelink Navigation Instruments | OLO | 2019-12-13 |
| 210005 | 1369239256 | K181246 | Zavation IBF System | MAX | 2018-07-10 |
| 210005 | 1369125398 | K181244 | Zavation Cervical Plate System | KWQ | 2018-07-10 |
| 210005 | 1419703530 | K180814 | CoreLink® M3 Stand-Alone Anterior Lumbar System | OVD | 2018-08-10 |
| 210005 | 1279898417 | K180673 | Normandy VBR System | PLR | 2018-07-13 |
| 210005 | 1431149638 | K180556 | Corelink Foundation 3D Anterior Lumbar System | MAX | 2018-07-27 |
| 210005 | 1997418306 | K180076 | Ti 3Z Interbody System | MAX | 2018-07-27 |
| 210005 | 2009543808 | K173752 | SI Screw System | OUR | 2018-03-16 |
| 210005 | 1808162638 | K173306 | EZ Plate | KWQ | 2018-01-22 |
| 210005 | 1353840737 | K171519 | FLXfit | MAX | 2017-09-15 |
| 210005 | 1085773448 | K163104 | Terrace Anterior Cervical Plate System | KWQ | 2017-06-21 |
| 210005 | 1979686130 | K162824 | Z-Span Plate System | KWQ | 2017-02-17 |
| 210005 | 1118440209 | K162575 | Z-LINKPC System | NKG | 2017-03-03 |
| 210005 | 1448180611 | K162496 | Foundation 3D Interbody | ODP | 2017-05-04 |
| 210005 | 1817041394 | K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) | NDN | 2016-11-01 |
| 210005 | 2022994181 | K162206 | Zavation IBF | MAX | 2017-04-04 |
| 210005 | 1200020450 | K161016 | Z-Clamp ISP System | PEK | 2016-10-19 |
| 210005 | 1738259569 | K160362 | Z-Span Plate System | KWQ | 2016-03-22 |
| 210005 | 1314539730 | K153404 | Zavation Spinal System | MNH | 2016-04-21 |
| 210005 | 1652440608 | K152237 | The Entasis Dual-Lead Sacroiliac Implant | OUR | 2016-02-04 |
| 210005 | 1895385274 | K150847 | Foundation Interbody Devices | ODP | 2015-08-13 |
| 210005 | 1162874439 | K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) | NDN | 2015-03-06 |
| 210005 | 1483566507 | K143228 | Ancora LLC Interbody Fusion Device | OVD | 2015-02-26 |
| 210005 | 1493368708 | K142392 | Zavation Posterior LEIF | MAX | 2015-04-29 |
| 210005 | 1130749146 | K142271 | Zavation Z-Link Lumbar | OVD | 2014-12-19 |
| 210005 | 1523520636 | K141419 | ZVPLASTY | NDN | 2014-09-12 |
| 210005 | 1909782345 | K141005 | Z-LINK CERVICAL | OVE | 2014-08-07 |
| 210005 | 1449557430 | K140844 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC | MQV | 2014-07-16 |
| 210005 | 1716039129 | K133813 | FLXFIT INTERVERTEBRAL BODY FUSION DEVICE | MAX | 2014-07-15 |
| 210005 | 1651097645 | K133369 | TIGER SPINE SYSTEM | NKB | 2014-01-14 |
| 210005 | 1980759098 | K132994 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2013-12-05 |
| 210005 | 1646265397 | K132620 | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL | NDN | 2014-04-16 |
| 210005 | 1408342402 | K132504 | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM | KWP | 2013-11-25 |
| 210005 | 1972457563 | K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | MRW | 2013-10-28 |
| 210005 | 1315492661 | K131250 | TIGER SPINE SYSTEM | NKB | 2013-09-10 |
| 210005 | 1553991404 | K130030 | ZAVATION CERVICAL PLATE SYSTEM | KWQ | 2013-04-25 |
| 210005 | 1029519755 | K121791 | ZOU ANTERIOR LUMBAR PLATE SYSTEM | KWQ | 2012-11-19 |
| 210005 | 1702440798 | K121728 | TIGER SPINE SYSTEM | NKB | 2012-10-05 |
| 210005 | 2010418080 | K121514 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2012-12-14 |
| 210005 | 1206548682 | K120696 | TIGER SPINE SYSTEM | MNI | 2012-04-02 |
| 210005 | 1676006030 | K120576 | ZAVATION IBF SYSTEM | MAX | 2012-03-28 |
| 210005 | 1608601343 | K113058 | TIGER SPINE SYSTEM | NKB | 2012-03-29 |
| 210005 | 1610859391 | K112700 | FRONTIER SADL INTERBODY FUSION DEVICE | OVD | 2012-11-01 |
| 210005 | 1572772510 | K112664 | ZAVATION IBF SYSTEMS | ODP | 2011-12-23 |
| 210005 | 1954915722 | K112533 | ZAVATION CERVICAL PLATE SYSTEM | KWQ | 2011-12-08 |
| 210005 | 2005618723 | K112484 | ZAVATION SPINAL SYSTEM | MNI | 2011-11-22 |
| 210005 | 1582409117 | K110321 | TIGER SPINE SYSTEM | MNH | 2011-05-25 |
| 210005 | 1871894155 | K102937 | OSTEOPHIL BETA-TCP | MQV | 2010-12-27 |
| 210005 | 1748870245 | K073440 | FOUNDATION CAGE | MAX | 2008-04-24 |
| 210005 | 1462082856 | K052812 | OSSIMEND (TM) BONE GRAFT MATERIAL | MQV | 2006-01-25 |
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| Product code | Registration listing records | Latest decision |
|---|---|---|
| MAX | 16 | 2024-04-10 |
| NKB | 12 | 2025-02-03 |
| KWQ | 12 | 2020-11-04 |
| OVD | 5 | 2023-06-14 |
| ODP | 5 | 2023-06-06 |
| OLO | 5 | 2023-05-02 |
| MQV | 5 | 2023-01-18 |
| OVE | 4 | 2022-08-12 |
| NDN | 4 | 2016-11-01 |
| OUR | 3 | 2023-03-21 |
| NKG | 3 | 2021-08-11 |
| PLR | 2 | 2019-08-06 |
| MNH | 2 | 2016-04-21 |
| MNI | 2 | 2012-04-02 |
| MQP | 1 | 2020-12-23 |
| PEK | 1 | 2016-10-19 |
| KWP | 1 | 2013-11-25 |
| MRW | 1 | 2013-10-28 |
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products LLC
Zavation Medical Products LLC
Zavation Medical Products LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products LLC
Zavation Medical Products LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products, LLC
Zavation Medical Products LLC
Zavation Medical Products, LLC
Zavation Medical Products LLC
Zavation Medical Products, LLc
Zavation Medical Products LLC
Zavation Medical Products LLC
Zavation Medical Products LLC
Zavation Medical Products LLC
Zavation Medical Products, LLC
Zavation Medical Products Llc
Zavation, LLC
ZAVATION, LLC
Zavation, LLC
Zavation, LLC
ZAVATION, LLC
Zavation, LLC
ZAVATION, LLC
Zavation, LLC
ZAVATION LLC
ZAVATION, LLC
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