Synthes USA

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010197348	3010197348	Synthes USA	1	N	2020-04-25	1210 Ward Ave West Chester PA US 19380

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
158190	1963608825	P070001	PRODISC TM-C TOTAL DISC REPLACEMENT	MJO	2007-12-17
158190	1799236197	P050010	PRODISC -L TOTAL DISC REPLACEMENT DEVICE	MJO	2006-08-14
158190	2040373875	P050010	PRODISC -L TOTAL DISC REPLACEMENT DEVICE	MJO	2006-08-14
158190	1979326789	K994364	SYNTHES BUTTON PLATE	MBI	2000-03-15
158190	1767473167	K994187	SYNTHES CERVIFIX SYSTEM	KWP	1999-12-21
158190	1677234597	K994161	SYNTHES BIORESORBABLE SUTURE ANCHOR	MAI	2000-07-28
158190	1185275357	K994121	SMALL STATURE USS	MNI	2000-10-17
158190	1358240838	K993335	SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM	HTO	2000-06-12
158190	1313223531	K993314	SYNTHES LIGHT GUIDE	FQP	1999-12-06
158190	1510491167	K992891	SYNTHES CERCLAGE POSITIONING PIN	JDQ	1999-11-02
158190	1320717995	K992837	3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)	KTW	1999-10-25
158190	1056417625	K992739	CLICK'X	MNH	2000-02-08
158190	1270524458	K992617	HEX BUTTON	HTN	1999-10-27
158190	1382361674	K992616	SDB CERCLAGE SYSTEM	JDQ	1999-10-27
158190	1184357412	K992348	SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)	JDS	1999-09-23
158190	1879920802	K992000	SYNTHES CRANIAL FLAP TUBE CLAMP	GXN	1999-07-20
158190	1251875950	K991860	SYNTHES CRANIAL FLAP TWIST CLAMP	GXN	1999-07-20
158190	1786620850	K991552	SYNTHES PEDIATRIC ROD SYSTEM	MNH	1999-06-02
158190	1498205691	K991407	SYNTHES LOCKING CALCANEAL PLATES	LXT	1999-06-11
158190	1353100319	K991089	SYNTHES CERVIFIX SYSTEM	KWP	1999-08-27
158190	1347616384	K991004	SYNTHES QUICK LOCK IMF SYSTEM	DYX	1999-06-23
158190	1783983571	K990965	SYNTHES CERVIFIX SYSTEM	KWP	1999-07-01
158190	1588402404	K990745	MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM	MNI	1999-03-30
158190	1468193880	K990637	SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD	NEI	1999-10-22
158190	1439673375	K984612	SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM	MNI	1999-01-19
158190	1450745994	K984498	SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM	KTT	1999-02-18
158190	1090452243	K984377	SYNTHES SPINE CERVIFIX SYSTEM	KWP	1999-01-21
158190	2072621255	K983787	SYNTHES PROXIMAL TIBIA PLATING SYSTEM	HRS	1999-01-21
158190	1595461307	K983766	SYNTHES SYNMESH	EZX	1998-12-18
158190	1139268263	K983530	SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM	KWP	1998-12-16
158190	1984599299	K983485	SYNTHES 1.3 MM SELF-DRILLING SCREW	DZL	1998-12-21
158190	1833747714	K982987	SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM	MNI	1998-10-21
158190	1519944925	K982732	SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)	HRS	1998-10-08
158190	1216956723	K982322	SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM	KWP	1998-11-25
158190	1271270583	K982222	SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM	HWC	1998-07-29
158190	1833874342	K981890	SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES	JEY	1998-08-18
158190	1428712946	K981757	SYNTHES (USA) DHS HELIX SYSTEM	JDO	1998-07-17
158190	1218192818	K981372	SYNTHES 3.0 MM PC-FIX SYSTEM	HWC	1998-05-11
158190	1448444230	K981362	SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR	DZL	1998-06-29
158190	1324113405	K981275	SYNTHES (USA) RATCHETING DISTRACTOR	MQN	1998-06-25
158190	1065213091	K981075	SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET	MQN	1998-06-22
158190	1351009053	K980944	SYNTHES SCHUHLI IMPLANT SYSTEM	HTN	1998-04-27
158190	1533029117	K980928	SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM	KWP	1998-05-11
158190	1079679983	K980761	SYNTHES SPINE PEDIATRIC ROD SYSTEM	MNH	1998-08-04
158190	1784059792	K980358	SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM	KWP	1998-04-16
158190	1840575767	K980199	SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS	DZL	1998-04-17
158190	1940599450	K974908	SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES	HRS	1998-03-18
158190	2006021350	K974555	SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)	JEY	1998-03-03
158190	1098644880	K974554	SYNTHES RESORBABLE FIXATION SYSTEM	JEY	1998-02-24
158190	1954031127	K974537	SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM	KTT	1998-02-18
158190	1403275692	K974525	SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM	KWQ	1998-03-02
158190	1184318858	K974206	SYNTHES CRANIAL SPRING CLIP (CSC)	GWO	1998-03-16
158190	2016272455	K973789	NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC	GXP	1998-05-18
158190	1051898018	K973240	SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION	HTY	1997-11-20
158190	2024461820	K973018	SYNTHES MINI LENGTHENING APPARATUS	MQN	1997-11-10
158190	1857553859	K973017	SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP	KTT	1997-10-16
158190	1056749980	K972516	SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM	JDS	1997-09-04
158190	1163573533	K971987	SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR	JEY	1997-06-24
158190	1277512265	K971883	SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM	KWQ	1997-10-16
158190	1178536798	K971783	SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM	HTY	1997-07-18
158190	1618380134	K971544	SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)	HWE	1997-05-28
158190	1365910962	K970733	SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM	HTY	1997-04-02
158190	2034641955	K970097	PROXIMAL FEMORAL NAIL (PFN) SYSTEM	JDW	1997-03-13
158190	1266725808	K970048	SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)	KWQ	1997-08-01
158190	2062506455	K964416	SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM	KWQ	1997-03-17
158190	1777898131	K964328	SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE	JEY	1996-12-13
158190	1429862248	K964261	SMF STAINLESS STEEL BONE SCREWS	DZL	1997-04-11
158190	1785754183	K964259	SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION	JDO	1997-01-09
158190	1142578913	K963798	SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM	HRS	1996-11-27
158190	1343905655	K963618	SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)	LXT	1996-11-12
158190	1651579765	K963546	SMF TITANIUM (TI) ALLOY BONE SCREWS	DZL	1997-06-24
158190	1107195519	K963357	MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE	MNH	1997-01-09
158190	1945648344	K963325	SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM	HRS	1997-03-25
158190	1977116083	K963192	SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS	HWC	1996-11-08
158190	1177443323	K963172	SYNTHES STERILE 4.5 MM CANNULATED SCREWS	HWC	1996-11-08
158190	1300642532	K963045	SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM	MNH	1997-02-13
158190	1230152201	K962913	SYNTHES STERILE DRILL BITS	HWE	1996-11-14
158190	1080653465	K962894	SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM	HRS	1996-12-17
158190	1863984346	K962823	SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER	HWC	1996-10-01
158190	1410252721	K962616	SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM	HRS	1996-09-03
158190	1037620460	K962608	SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR	MNH	1996-12-09
158190	1241181743	K962484	SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)	KTT	1996-09-05
158190	1421474641	K962272	SYNTHES MANDIBLE DISTRACTOR	MQN	1996-08-30
158190	1458841525	K962047	TITANIUM CANNULATED TIBIAL NAIL (TI CTN)	JDS	1996-07-24
158190	1590238976	K962011	SYNTHES 7.0/7.3 MM CANNULATED SCREWS	HWC	1996-08-05
158190	1499451803	K961608	SYNTHES (U.S.A.) POLYPIN	HTY	1997-05-09
158190	1728353571	K961421	SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM	JEY	1996-06-26
158190	1944340038	K961413	SYNTHES ANATOMICAL LOCKING PLATE SYSTEM	HWC	1996-08-07
158190	1773315026	K961350	SYNTHES MINI EXTERNAL FIXATOR	KTT	1996-06-28
158190	1696341999	K960782	TITANIUM TUBE TO TUBE CLAMP	JEC	1996-05-08
158190	1866657643	K960269	TITANIUM UNIVERSAL CLAMP	LXT	1996-04-04
158190	2021747986	K954963	SCHUHLI IMPLANT SYSTEM	HRS	1996-03-22
158190	1329704138	K954856	CANNULATED FEMORAL NAIL	JDN	1996-03-08
158190	1854004362	K954385	SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM	JEY	1996-03-08
158190	1119706616	K954289	SYNTHES CANNULATED ANGLE BLADE PLATE	KTW	1995-11-24
158190	1440855168	K953806	SYNTHES (USA) MIDFACIAL SYSTEM	JEY	1996-03-08
158190	1053985535	K953777	SYNTHES WIRE MOUNT	JDQ	1996-03-08
158190	1085866931	K953644	VOLAR DISTAL RADIUS PLATE	HRS	1996-03-08
158190	1295828482	K953607	TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)	JDO	1996-03-08
158190	1543911973	K953334	SYNTHES FLEXNAIL	HSB	1995-10-31
158190	1615228679	K952296	SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW	HWC	1995-08-18
158190	1743473076	K952272	TI. ALLOY 2.0 MM CORTEX SCREW	HWC	1995-07-31
158190	1273073979	K951904	SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]	JDO	1995-07-17
158190	1498415508	K951794	SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)	MNH	1995-08-21
158190	1923496937	K951626	SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM	MNH	1995-08-21
158190	1661513399	K951304	SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER	HWC	1995-06-16
158190	2067940317	K950384	SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR	LXT	1995-05-22
158190	1347124395	K945700	SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM	KWQ	1995-07-20
158190	1659813468	K943725	UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM	KWQ	1995-08-25
158190	1344853791	K933518	SYNTHES UNREAMED HUMERAL NAIL (URHN)	HSB	1994-03-14
158190	1939259325	K932593	ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL	HSB	1994-03-10
158190	2048430921	K932330	TI-6AL-7NB URTN	HSB	1996-03-08
158190	1017316721	K930891	SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST	KWP	1994-04-29
158190	1298210080	K926453	SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE	KWQ	1993-10-12
158190	1818548502	K925460	SYNTHES STERILE PINLESS EXTERNAL FIXATOR	KTT	1994-03-10
158190	1191821621	K925351	SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE	KWQ	1993-11-05
158190	1884434153	K924455	SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER	HTN	1993-05-12
158190	1211493592	K923613	SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT	JDO	1993-06-22
158190	2026326681	K923597	SYNTHES TITANIUM UNREAMED FEMORAL NAIL	HSB	1993-01-21
158190	1631534005	K923580	SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL	HSB	1993-01-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HRS	111	2019-05-03
JEY	42	2014-10-17
KTT	35	2018-10-16
HWC	34	2013-12-16
HSB	28	2017-11-14
KWQ	27	2015-12-02
KWP	21	2014-10-01
MQN	15	2017-05-08
NKB	14	2012-07-31
LXT	14	2008-01-29
DZL	13	2010-01-25
MNI	12	2012-02-01
JDQ	12	2011-07-28
JDS	11	2011-12-05
MQP	10	2011-10-20
MQV	9	2011-01-27
MNH	9	2006-07-12
KTW	8	2008-03-20
HTN	6	2002-02-08
MAX	5	2015-06-18
OVE	5	2012-07-25
HTY	5	2001-04-09
JDO	5	1998-07-17
GWO	4	2014-06-13
NDN	4	2013-05-20
HTO	4	2011-08-10
GXP	4	2010-09-23
JEC	4	2007-08-24
GXN	4	2005-12-14
JDW	4	2004-04-12
NEI	3	2008-09-05
MJO	3	2007-12-17
HWE	3	2005-01-05
GXR	3	2004-11-17
JDR	2	2020-02-26
OVD	2	2015-08-21
GXQ	2	2013-12-16
KKY	2	2011-11-16
OAT	2	2010-12-16
NQP	2	2007-10-19

PMN#

DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
2015-03-30
SYNTHES USA
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
2012-07-06
SYNTHES USA
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
2012-06-18
SYNTHES USA
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
2012-05-08
SYNTHES USA
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
2012-03-21
SYNTHES USA
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
2012-02-08
SYNTHES USA
3.7MM/5.0MM DYNAMIC LOCKING SCREW
2011-07-25
SYNTHES USA
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
2011-04-21
SYNTHES USA
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
2011-03-04
SYNTHES USA