Total Temporomandibular Joint Replacement System
BIOMET MICROFIXATION, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1032347 | 1032347 | BIOMET MICROFIXATION | 1 | N | 2026-01-01 | 1520 Tradeport Dr Jacksonville FL US 32218 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00888233016902 | N/A - SP-2482 | +1(904)741-4400 | FXJAX-ORDERS@ZIMMERBIOMET.COM |
| 00888233018227 | 2.0MM SYSTEM - SP-2640 | +1(904)741-4400 | FXJAX-ORDERS@ZIMMERBIOMET.COM |
| 00888233025379 | LactoSorb System - Mandibular - SP-1778 | +1(904)741-4400 | FXJAX-ORDERS@ZIMMERBIOMET.COM |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 28267 | 1013060902 | P020016 | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | LZD | 2005-09-21 |
| 28267 | 1317338145 | K992961 | LORENZ SMALL FRAGMENT SYSTEM | HRS | 1999-11-08 |
| 28267 | 1859980973 | K992952 | LORENZ DISTRACTION SYSTEM | MQN | 1999-11-19 |
| 28267 | 1472800172 | K992355 | LACTOSORB TRAUMA PLATING SYSTEM | HRS | 1999-12-20 |
| 28267 | 1684830220 | K992158 | LACTOSORB SHEETS | JEY | 1999-08-20 |
| 28267 | 1879130763 | K990290 | CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER | GXP | 1999-11-18 |
| 28267 | 1156603292 | K983728 | LORENZ IMF SCREW | DZL | 1999-05-13 |
| 28267 | 1449754667 | K981789 | LORENZ PECTUS SUPPORT BAR STABILIZER | HRS | 1998-07-13 |
| 28267 | 1154749478 | K981070 | 20-HOLE ADAPTATION PLATE | JEY | 1998-05-20 |
| 28267 | 1581415731 | K980927 | LACTOSORB PANELS AND FASTENERS | JEY | 1998-06-05 |
| 28267 | 2031446665 | K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW | JEY | 1998-05-11 |
| 28267 | 1229699384 | K974309 | LACTOSORB PANELS | HRS | 1998-01-30 |
| 28267 | 1877518770 | K974136 | CRANIOFACIAL ANCHORS | MBI | 1998-01-30 |
| 28267 | 1188307185 | K973080 | SURGICAL VASCULAR CLAMP | DXC | 1998-02-23 |
| 28267 | 1679758144 | K972420 | LORENZ PECTUS SUPPORT BAR | HRS | 1997-08-11 |
| 28267 | 1369293463 | K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES | JEY | 1997-08-18 |
| 28267 | 1876207441 | K972074 | SUCTION INSTRUMENTATION | GCX | 1997-07-25 |
| 28267 | 1600712248 | K971870 | LACTOSORB TRAUMA PLATING SYSTEM | HRS | 1997-08-19 |
| 28267 | 1104533822 | K955729 | LACTOSORB TRAUMA PLATING SYSTEM | HRS | 1996-02-14 |
| 28267 | 1604185006 | K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM | JEY | 1995-09-28 |
| 28267 | 2034954231 | K941245 | POLY-MEDICS HEAT PACK | IMD | 1994-05-02 |
| 28267 | 1785538746 | K924935 | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT | KKY | 1993-09-02 |
| 28267 | 1605238705 | K922741 | LORENZ 1.0 MM SYSTEM | JEY | 1992-12-23 |
| 28267 | 1431612711 | K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM | JEY | 1991-02-20 |
| 28267 | 1492884083 | K896667 | LORENZ STENT | FWN | 1990-02-22 |
| 28267 | 1013077894 | K854886 | WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS | JEY | 1986-01-21 |
| 28267 | 1641729592 | K831005 | WIRE & STEINMAN PINS | HTY | 1983-05-18 |
| 28267 | 1429951901 | K241709 | Pectus Blu Support Bar System | HRS | 2024-09-19 |
| 28267 | 1671289857 | K241282 | RibFix Titan Fixation System | HRS | 2024-08-19 |
| 28267 | 1647707006 | K223199 | 2.1 x 255mm Drill, 22mm Stop | HBE | 2022-11-15 |
| 28267 | 1057532968 | K213072 | 2.1 x 255mm Drill, 22mm Stop | HBE | 2022-08-23 |
| 28267 | 1584572239 | K212841 | Pectus Blu Support Bar System | HRS | 2022-01-07 |
| 28267 | 1520282352 | K212782 | SternaLock Sternal Closure System | HRS | 2022-05-17 |
| 28267 | 1971142024 | K212608 | RibFix Blu Thoracic Fixation System | HRS | 2022-04-22 |
| 28267 | 1697970804 | K210290 | JACE Medical Thoracic Plating System | HRS | 2021-04-30 |
| 28267 | 1333791865 | K203474 | Biomet Microfixation RibFix Advantage System | HRS | 2021-01-28 |
| 28267 | 1002922850 | K202969 | Biomet Microfixation OmniMax MMF System | JEY | 2021-08-05 |
| 28267 | 1269332775 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | OCV | 2019-06-05 |
| 28267 | 1918926167 | K183317 | AdvantageRib System | HRS | 2019-02-14 |
| 28267 | 1779129224 | K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | HRS | 2016-11-23 |
| 28267 | 1989612245 | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HRS | 2016-12-09 |
| 28267 | 1593958088 | K161896 | Biomet Microfixation Sternal Closure System | HRS | 2016-08-02 |
| 28267 | 1320274978 | K152326 | Biomet Microfixation OmniMax MMF System | JEY | 2015-12-10 |
| 28267 | 1626495558 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HRS | 2016-03-24 |
| 28267 | 1511969574 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HWC | 2015-05-26 |
| 28267 | 1357354333 | K151019 | SternaLock® 360 Sternal Closure System | HRS | 2015-11-03 |
| 28267 | 1948428932 | K143336 | Biomet Microfixation OmniMax MMF System | JEY | 2015-04-01 |
| 28267 | 1097855466 | K142823 | Biomet Microfixation Thoracic Fixation System | HRS | 2015-02-25 |
| 28267 | 1057647116 | K142484 | Sternal Closure System | HRS | 2014-10-31 |
| 28267 | 1087023835 | K141241 | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM | HRS | 2014-08-07 |
| 28267 | 1600311537 | K140603 | ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM | GEI | 2014-07-31 |
| 28267 | 1008804555 | K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY | 2013-10-02 |
| 28267 | 1893599956 | K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY | 2013-08-08 |
| 28267 | 1693262390 | K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM | GWO | 2012-10-12 |
| 28267 | 1648744813 | K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | JEY | 2012-09-21 |
| 28267 | 1017550273 | K121302 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | HRS | 2012-09-19 |
| 28267 | 2042263035 | K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM | JEY | 2012-06-29 |
| 28267 | 2017541048 | K112671 | STERILCONTAINER SYSTEM | KCT | 2012-05-04 |
| 28267 | 1178104023 | K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | HWC | 2011-11-29 |
| 28267 | 1788073058 | K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM | HRS | 2011-05-18 |
| 28267 | 1832264397 | K101080 | NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX | GEI | 2010-06-21 |
| 28267 | 1467945194 | K091058 | ADKINS STRUT | HRS | 2009-07-22 |
| 28267 | 1183409608 | K082793 | INTERGRO DBM | MQV | 2009-04-02 |
| 28267 | 1654627969 | K082293 | SURGVIEW INTEGRATED VISUALIZATION SYSTEM | HRX | 2008-09-09 |
| 28267 | 1410929204 | K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | JEY | 2008-05-09 |
| 28267 | 1544872769 | K063506 | LORENZ STERNAL CLOSURE SYSTEM | HRS | 2006-12-18 |
| 28267 | 1514491319 | K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | OAT | 2007-02-09 |
| 28267 | 1375043894 | K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | JEY | 2007-01-12 |
| 28267 | 1431772106 | K062842 | TWIST DRILL | HBE | 2006-12-04 |
| 28267 | 1956261629 | K062510 | AESCULAP STERILCONTAINER SYSTEM | FRG | 2006-11-17 |
| 28267 | 1734874324 | K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | HRS | 2006-06-06 |
| 28267 | 1981019428 | K050322 | MICROTEK EQUIPMENT DRAPES | KKX | 2005-05-17 |
| 28267 | 2007666657 | K042516 | OTOMIMIX | NEA | 2004-11-08 |
| 28267 | 1721979314 | K040983 | LORENZ SELF-DRILLING IMF SCREW | DZE | 2004-05-05 |
| 28267 | 1066512725 | K033740 | LORENZ STERNAL CLOSURE SYSTEM | HWC | 2003-12-15 |
| 28267 | 1387816505 | K031751 | RAPIDFIRE SELF DRILLING SCREWS | HWC | 2003-06-26 |
| 28267 | 1811964145 | K031034 | SPIN DOWN RAPIDFLAP | GXN | 2003-05-21 |
| 28267 | 1384061527 | K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | JEY | 2004-05-14 |
| 28267 | 1249282012 | K023718 | QUICKSET MIMIX BONE VOID FILLER | GXP | 2002-12-04 |
| 28267 | 1338533332 | K020407 | LORENZ BLUE DEVICE | MQN | 2002-02-22 |
| 28267 | 1753306928 | K013954 | LORENZ SELF DRILLING SCREWS | HWC | 2002-02-28 |
| 28267 | 2068006617 | K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW | MBI | 2001-11-16 |
| 28267 | 1259705703 | K012409 | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS | NHB | 2001-10-18 |
| 28267 | 1117148963 | K011139 | LORENZ LACTOSORB PANELS AND FASTENERS | HRS | 2001-12-20 |
| 28267 | 1061949921 | K011076 | LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW | HRS | 2001-07-16 |
| 28267 | 1826351617 | K003281 | LACTOSORB RAPIDFLAP | JEY | 2001-08-07 |
| 28267 | 1795203663 | K002790 | ADD-ON CONDYLE | NEI | 2001-08-06 |
| 28267 | 1286481696 | K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM | JEY | 2001-02-12 |
| 28267 | 1136208575 | K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | JEY | 2000-05-03 |
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| Product code | Registration listing records | Latest decision |
|---|---|---|
| HRS | 30 | 2024-09-19 |
| JEY | 22 | 2021-08-05 |
| HWC | 5 | 2015-05-26 |
| HBE | 3 | 2022-11-15 |
| GEI | 2 | 2014-07-31 |
| GXP | 2 | 2002-12-04 |
| MQN | 2 | 2002-02-22 |
| MBI | 2 | 2001-11-16 |
| OCV | 1 | 2019-06-05 |
| GWO | 1 | 2012-10-12 |
| KCT | 1 | 2012-05-04 |
| MQV | 1 | 2009-04-02 |
| HRX | 1 | 2008-09-09 |
| OAT | 1 | 2007-02-09 |
| FRG | 1 | 2006-11-17 |
| LZD | 1 | 2005-09-21 |
| KKX | 1 | 2005-05-17 |
| NEA | 1 | 2004-11-08 |
| DZE | 1 | 2004-05-05 |
| GXN | 1 | 2003-05-21 |
| NHB | 1 | 2001-10-18 |
| NEI | 1 | 2001-08-06 |
| DZL | 1 | 1999-05-13 |
| DXC | 1 | 1998-02-23 |
| GCX | 1 | 1997-07-25 |
| IMD | 1 | 1994-05-02 |
| KKY | 1 | 1993-09-02 |
| FWN | 1 | 1990-02-22 |
| HTY | 1 | 1983-05-18 |
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
Biomet Microfixation
Biomet Microfixation
Biomet Microfixation
Biomet Microfixation
Biomet Microfixation
Biomet Microfixation
Biomet Microfixation
Biomet Microfixation
Biomet Microfixation
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
Biomet Microfixation
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
BIOMET MICROFIXATION, INC.
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