SIMAGEC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010462278 | 3010462278 | SIMAGEC | 1 | N | 2026-01-01 | 54 avenue de la Plaine Z.I. ROUSSET CEDEX Bouches-du-Rhone FR 13106 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 162534 | 1939378246 | K991566 | SOLUSTAPLE | JDR | 1999-08-03 |
| 162534 | 1985864511 | K991477 | SPIN SNAP-OFF SCREW | HWC | 1999-07-14 |
| 162534 | 1020631616 | K990622 | BOLD SCREW | HWC | 1999-04-29 |
| 162534 | 1231878466 | K161414 | Anatomic Total Knee System | JWH | 2017-01-19 |
| 162534 | 1330638394 | K161173 | Avenue® T TLIF Cage | OVD | 2016-09-28 |
| 162534 | 1202119374 | K152137 | FacetBRIDGE System | MRW | 2016-01-25 |
| 162534 | 1160202092 | K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | PEK | 2014-03-07 |
| 162534 | 1556906038 | K123134 | EASYSPINE SYSTEM | NKB | 2013-02-01 |
| 162534 | 1947476993 | K121103 | LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S | NKB | 2012-08-24 |
| 162534 | 1089620631 | K093914 | NEWDEAL COMPRESSION PLATES | HRS | 2011-04-14 |
| 162534 | 1731201192 | K093781 | MODIFIED: NEWDEAL HALLU PLATES | HRS | 2010-01-22 |
| 162534 | 1234627930 | K091788 | PANTA NAIL (DIA. 10MM), PANTA NAIL XL | HSB | 2009-07-29 |
| 162534 | 1242074240 | K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | ODP | 2009-07-14 |
| 162534 | 1469100686 | K083154 | NEWDEAL HALLU LOCK PLATE SYSTEM | HRS | 2009-07-10 |
| 162534 | 1023606372 | K073375 | NEWDEAL TIBIAXYS SYSTEM | HRS | 2008-02-21 |
| 162534 | 1429646442 | K071639 | QWIX POSITIONING SCREW | HWC | 2007-07-09 |
| 162534 | 1558763458 | K070241 | MODIFICATION TO LAPIDUS PLATE | HRS | 2007-02-08 |
| 162534 | 1319075274 | K070160 | MODIFICATION TO TTC PLATES | HRS | 2007-02-08 |
| 162534 | 1298398811 | K063820 | LISFRANC PLATE | HRS | 2007-02-08 |
| 162534 | 1651852760 | K060476 | LAPIDUS PLATE | HRS | 2006-05-17 |
| 162534 | 1966738049 | K060474 | LISFRANC PLATE | HRS | 2006-08-03 |
| 162534 | 1679413165 | K060473 | TTC PLATE | HRS | 2006-05-17 |
| 162534 | 1117450225 | K050882 | NEWDEAL ANKLE NAIL | HSB | 2005-05-27 |
| 162534 | 1810866067 | K050346 | STABILIZATION SCREW | HWC | 2005-03-17 |
| 162534 | 1722637406 | K041601 | SURFIX KNEE OSTEOTOMY SYSTEM | HRS | 2004-08-27 |
| 162534 | 1188302468 | K022599 | NEWDEAL K WIRE | HTY | 2002-10-30 |
| 162534 | 1579671170 | K022597 | K-FIX | HTY | 2002-11-01 |
| 162534 | 1927302818 | K021626 | HALLU PLATES | HRS | 2002-08-12 |
| 162534 | 1512362259 | K011946 | THE SPIN SNAP-OFF SCREW | HWC | 2001-08-24 |
| 162534 | 1959541845 | K011262 | MODIFICATION TO THE BOLD SCREW | HWC | 2001-06-15 |
| 162534 | 1235041428 | ||||
| 162534 | 1632421986 | ||||
| 162534 | 2047841307 | ||||
| 162534 | 1017723338 | ||||
| 162534 | 1020289715 | ||||
| 162534 | 1020418206 | ||||
| 162534 | 1047469925 | ||||
| 162534 | 1054776304 | ||||
| 162534 | 1061296615 | ||||
| 162534 | 1079377193 | ||||
| 162534 | 1081505057 | ||||
| 162534 | 1089620631 | ||||
| 162534 | 1094068254 | ||||
| 162534 | 1100150458 | ||||
| 162534 | 1140577700 | ||||
| 162534 | 1165593659 | ||||
| 162534 | 1199500985 | ||||
| 162534 | 1200229551 | ||||
| 162534 | 1207900489 | ||||
| 162534 | 1219870968 | ||||
| 162534 | 1231564732 | ||||
| 162534 | 1233439665 | ||||
| 162534 | 1238130036 | ||||
| 162534 | 1298398811 | ||||
| 162534 | 1320267231 | ||||
| 162534 | 1346286189 | ||||
| 162534 | 1363800672 | ||||
| 162534 | 1385719868 | ||||
| 162534 | 1420143493 | ||||
| 162534 | 1437802325 | ||||
| 162534 | 1465682069 | ||||
| 162534 | 1474310259 | ||||
| 162534 | 1477923353 | ||||
| 162534 | 1493377434 | ||||
| 162534 | 1493572030 | ||||
| 162534 | 1495633358 | ||||
| 162534 | 1508207396 | ||||
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| 162534 | 1543134875 | ||||
| 162534 | 1595816651 | ||||
| 162534 | 1628844457 | ||||
| 162534 | 1629835789 | ||||
| 162534 | 1638521327 | ||||
| 162534 | 1644196546 | ||||
| 162534 | 1662376016 | ||||
| 162534 | 1673306280 | ||||
| 162534 | 1704825011 | ||||
| 162534 | 1709148058 | ||||
| 162534 | 1724489175 | ||||
| 162534 | 1730218330 | ||||
| 162534 | 1758606910 | ||||
| 162534 | 1766598085 | ||||
| 162534 | 1781827464 | ||||
| 162534 | 1793896484 | ||||
| 162534 | 1798437620 | ||||
| 162534 | 1799244894 | ||||
| 162534 | 1817020253 | ||||
| 162534 | 1847334522 | ||||
| 162534 | 1859957173 | ||||
| 162534 | 1863370676 | ||||
| 162534 | 1873221059 | ||||
| 162534 | 1874460955 | ||||
| 162534 | 1876718744 | ||||
| 162534 | 1877952758 | ||||
| 162534 | 1891924949 | ||||
| 162534 | 1895049921 | ||||
| 162534 | 1898722039 | ||||
| 162534 | 1928697977 | ||||
| 162534 | 1968346406 | ||||
| 162534 | 1969204823 | ||||
| 162534 | 1981862226 | ||||
| 162534 | 1987738906 | ||||
| 162534 | 2011450653 | ||||
| 162534 | 2028059746 | ||||
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| 162534 | 2041723525 | ||||
| 162534 | 2051417006 | ||||
| 162534 | 2059239612 |