WARSAW ORTHOPEDIC, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1824199	1824199	WARSAW ORTHOPEDIC, INC.	1	Y	2026-01-01	2500 SILVEUS CROSSING WARSAW IN US 46582

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
5810	1954472080	P970015	INTER FIX THREADED FUSION DEVICE	MAX	1999-05-14
5810	1520450386	P090029	PRESTIGE LP CERVICAL DISC	MJO	2014-07-24
5810	1296359699	P060023	BRYAN CERVICAL DISC PROSTHESIS	MJO	2009-05-12
5810	2030597229	P060018	PRESTIGE CERVICAL DISC SYSTEM	MJO	2007-07-16
5810	1596660047	P000058	INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE	NEK	2002-07-02
5810	1935647279	P000028	AFFINITY (TM) CAGE SYSTEM	MAX	2002-06-13
5810	1791905019	K994239	ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM	KWQ	2000-06-19
5810	1942544278	K994122	BONE GRAFT WASHER, MODEL 9090114 - 9090118	KWQ	2000-02-18
5810	1331165389	K993855	ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM	KWQ	1999-12-15
5810	2018734928	K993810	CD HORIZON SPINAL SYSTEM	MNH	2000-02-03
5810	1062976338	K993021	METRX SYSTEM	HRX	1999-11-10
5810	1283829531	K992928	CD HORIZON SPINAL SYSTEM	MNI	1999-09-21
5810	1999960604	K992110	PREMIER ANTERIOR CERVICAL PLATE SYSTEM	KWQ	1999-09-14
5810	1521473404	K991528	MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR	MNH	1999-05-28
5810	1015159206	K991460	MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM	MNH	1999-05-19
5810	1651344753	K991364	MODIFICATION TO TENOR SPINAL SYSTEM-PLATES	MNH	1999-05-19
5810	1687414764	K991198	DYNA-LOK PLUS SPINAL SYSTEM	KWP	1999-08-27
5810	1010808771	K991036	DANEK PLATE AND SCREW SYSTEM	MNH	1999-09-14
5810	1490627623	K991031	COLORADO II SPINAL SYSTEM	MNH	2000-05-10
5810	2002677408	K990603	MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM	KWQ	1999-03-10
5810	1258968485	K984522	MODIFICATION OF TSRH SPINAL SYSTEM	MNI	1999-01-06
5810	1387689553	K984360	COLORADO II SPINAL SYSTEM	MNH	2000-03-30
5810	1753808401	K983706	MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM	KWP	1998-11-12
5810	1415003778	K983672	DYNA-LOK SPINAL SYSTEM	MNI	1998-12-16
5810	1960338766	K982990	TSRH SPINAL SYSTEM	MNI	1998-10-21
5810	2068018505	K982875	MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM	KWQ	1999-01-19
5810	1520150763	K982686	MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM	MNI	1998-08-07
5810	1720810943	K982490	TENOR SPINAL SYSTEM	KWP	1998-10-05
5810	2015589731	K982154	MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM	MNI	1998-07-13
5810	1585121147	K981676	CD HORIZON SPINAL SYSTEM	KWP	1999-01-28
5810	1537207222	K980184	CD SPINAL SYSTEM	MNI	1998-12-18
5810	1971712798	K973854	ORION ANTERIOR CERVICAL PLATE SYSTEM	KWQ	1998-03-16
5810	1736191801	K970806	ACPII ANTERIOR CERVICAL PLATE SYSTEM	KWQ	1997-05-02
5810	1409848288	K970599	TOWNLEY PEDICLE SCREW PLATING SYSTEM	MNI	1998-03-20
5810	1891189775	K965193	LIBERTY ANTERIOR SPINAL SYSTEM	KWQ	1997-03-17
5810	1790811986	K964623	TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM	KWQ	1997-02-06
5810	1154504240	K964275	ALPHA POSTERIOR SPINAL SYSTEM	KWP	1997-01-14
5810	1806894514	K964254	TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM	KWP	1997-04-21
5810	1412875585	K964159	CD SPINAL SYSTEM	KWP	1997-10-16
5810	1850025970	K963780	DUAL ROD ANTERIOR FIXATOR SYSTEM	KWQ	1997-07-30
5810	1462676179	K963655	CD HORIZON ANTERIOR SPINAL SYSTEM	KWQ	1996-11-27
5810	1373748860	K963642	INCL II ENDOSCOPE	GWG	1998-03-18
5810	1846753732	K962708	TITANIUM CD HORIZON SPINAL SYSTEM	KWP	1997-02-06
5810	1563922525	K961633	CD HORIZON SPINAL SYSTEM	KWP	1996-12-05
5810	1043362474	K955807	COTREL-DUBOUSSET (CD) SPINAL	KWP	1996-10-01
5810	1642468742	K955471	INCL ENDOSCOPE	HRX	1995-12-18
5810	1157825981	K955365	COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM	KWP	1996-03-27
5810	1697709122	K954645	TITANIUM GDLH POSTERIOR SPINAL SYSTEM	KWP	1996-01-16
5810	1466048614	K953635	TITANIUM DYNA-LOK SPINAL SYSTEM	MNH	1995-10-30
5810	1254120006	K953076	TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM	MRW	1997-02-28
5810	1706553644	K951164	CD LIBERTY POSTERIOR SPINCAL SYSTEM	KWP	1996-02-09
5810	1596499608	K950955	PARAGON POSTERIOR SPINAL SYSTEM	MNH	1995-08-25
5810	1089783813	K950717	AUGMENT-T POSTERIOR SPINAL SYSTEM	MNH	1996-02-14
5810	1726152151	K950596	GDLH POSTERIOR SPINAL SYSTEM	MNH	1995-08-28
5810	1256492282	K950501	DANEK RIGID ARTHROSCOPE	HRX	1995-05-12
5810	1138758898	K950130	MICRO-ENDO(TM) INSTRUMENTS	HRX	1995-05-01
5810	1277445944	K946348	TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)	MNH	1995-08-07
5810	1367893110	K946087	INCLUSICE II(TM) ENDOSCOPE	HRX	1995-11-21
5810	1744379142	K945022	APOFIX CERVICAL SPINE FIXATION	KWP	1995-05-15
5810	1937209296	K943827	SPINE FIXATION	MNH	1996-02-14
5810	1629683869	K943676	DANEKSCOPE OPTI-PROBE	HRX	1994-11-21
5810	1538231040	K943356	INCLUSIVE ENDOSCOPE	HRX	1995-05-10
5810	1945533144	K940744	SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION	KWQ	1996-01-30
5810	1872218526	K936307	DYNA-LOK ANTERIOR PLATING SYSTEM	MNH	1995-08-14
5810	1421175831	K936294	SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS	KWP	1995-12-19
5810	1298784237	K934582	GDLH VARIABLE ANGLE CONNECTOR	KWP	1994-06-21
5810	1163323272	K934007	SOFAMOR ORFIL SPINE FIXATION SYSTEM	KWP	1994-06-02
5810	1375419596	K933242	SOFAMOR ORTHOPAEDIC INSTRUMENTS	LXH	1994-01-28
5810	1260853652	K933205	TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON	KWP	1994-05-04
5810	1340568189	K932029	TSRH SPINAL SCREWS	MNH	1995-01-20
5810	1291644670	K930807	SENTRY ANTERIOR SPINAL SYSTEM	KWQ	1993-10-01
5810	1190629329	K930710	SENTRY POSTERIOR SPINAL SYSTEM	KWP	1993-10-01
5810	1845030859	K930191	DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY	HRX	1995-09-26
5810	1413631021	K925812	TITANIUM SONGER CABLE SYSTEM	JDQ	1993-03-24
5810	1935086727	K925811	TSRH CENTRAL POST HOOKS	KWP	1993-05-18
5810	1181836011	K925577	DANEK TISSUE RESECTING SYSTEM	HRX	1993-04-08
5810	1215798237	K924085	RECONSTRUCTION PLATE SYSTEM	HRS	1992-12-17
5810	1378087995	K923446	STERILE DYNA LOK ANTERIOR PLATING SYSTEM	KWQ	1992-12-17
5810	1651956966	K923339	TSRH L CONNECTOR -- MODIFICATION	KWP	1992-10-27
5810	1106019015	K923242	CROSSLINK AXIAL AND OFFSET PLATES	KWQ	1993-05-19
5810	1499850491	K922672	AUGMENT POSTERIOR SPINAL FIXATION SYSTEM	KWP	1993-05-18
5810	1948975328	K922543	Z-PLATE ANTERIOR FIXATION SYSTEM	KWQ	1993-05-19
5810	1770145259	K922520	MODIFIED TSRH CENTRAL POST HOOKS	KWP	1992-11-16
5810	1072042227	K922486	DANEK TISSUE CUTTING AND REMOVAL SYSTEM	HRX	1993-10-12
5810	1577722432	K922087	ANTERIOR CERVICAL PLATE SYSTEM	KWQ	1992-11-06
5810	1297978924	K921767	COMPACT COTREL -- DUBOUSSET SPINE SYSTEM	KWP	1993-06-22
5810	1877544524	K921256	LUQUE V SPINAL SYSTEM	KWP	1993-05-18
5810	1486172647	K921056	COTREL - DUBOUSSET SPINE IMPLANTS	KWP	1993-06-24
5810	1214293967	K920546	PARAGON POSTERIOR SPINAL SYSTEM	KWP	1993-01-21
5810	1842072482	K920201	TITANIUM ALLOY SONGER CABLE SYSTEM	JDQ	1992-04-08
5810	2052132282	K920118	RESORABPLUG	LZN	1993-02-08
5810	1782021626	K914966	TSRH CENTRAL POST HOOKS	KWP	1992-05-12
5810	1134038528	K914306	TSRH(TM) LATERAL OFFSET PLATE	KWP	1992-06-19
5810	1828362597	K913735	SONGER(TM) CABLE SYSTEM	JDQ	1991-11-18
5810	1210593809	K911729	DANEKSCOPE AND ACCESSORIES	HRX	1993-04-05
5810	2070046687	K911379	DANEK SACRAL HOOK, MODIFICATION	KWP	1991-09-11
5810	1805456335	K911319	TSRH OPEN HEAD BONE SCREW	KWP	1991-09-06
5810	1221658478	K911307	CROSSLINK PLATE	KWP	1991-10-24
5810	1895383880	K911306	T-BOLT AND NUT	HTN	1991-09-10
5810	1940182379	K911300	MICROSURGICAL INSTRUMENTS	HRX	1991-04-05
5810	1790335540	K904520	RAY SACRAL FIXATION SYSTEM	KWP	1991-10-25
5810	2025414617	K904243	TSRH VARIABLE ANGLE SACRAL SCREW	KWP	1992-01-22
5810	1952537913	K903676	STERNOTOMY CABLE, SONGER CABLE SYSTEM	JDQ	1990-09-10
5810	1505392034	K903461	TSRH OFFSET AND SIDE-LOADING HOOKS	KWP	1990-12-05
5810	1820196329	K902775	KNIGHT SACRAL SCREW	KWP	1990-12-10
5810	1477588614	K901692	DANEK SPINALSCOPE	HRX	1992-02-14
5810	2004900606	K901587	TSRH SACRAL L-CONNECTOR	KWP	1990-11-05
5810	1815218858	K901005	TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)	KWP	1990-12-10
5810	1835346380	K897141	SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO	JDN	1990-06-21
5810	1069263046	K896740	AXIAL AND OFFSET CROSSLINK PLATES	KWP	1990-02-26
5810	2035686174	K896603	HSC UNIT ROD	KWP	1990-01-30
5810	1055677097	K896254	DANEK PRECISION ROD SET	KWP	1990-06-14
5810	1156204346	K895978	CHIBA SPINAL SYSTEM	KWP	1990-08-09
5810	1934542343	K894702	STUART CD UNIVERSAL ROD CONNECTOR CLAMPS	KWP	1989-10-11
5810	1995310122	K892651	SONGER WIRING SYSTEM	LRN	1989-07-25
5810	1142760038	K890601	STUART TITANIUM SURGICAL MESH	EZX	1989-03-16
5810	1170044370	K890192	LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET	KWP	1990-01-04
5810	1756097420	K883784	TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE	LYQ	1989-04-06
5810	1042133273	K883783	TSRH SACRAL SPINAL SCREW	KWP	1989-04-06
5810	1213993608	K881327	STUART CANNULATED CANCELLOUS BONE FIXATION SCREW	HWC	1988-05-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KWP	104	2013-04-01
NKB	82	2025-10-24
KWQ	45	2015-11-12
MNI	33	2006-12-22
MNH	33	2006-07-25
MAX	24	2026-07-17
MQP	16	2019-04-04
HRX	16	2005-01-25
NQP	5	2021-01-15
JDK	5	2001-12-05
NKG	4	2026-01-21
OLO	4	2023-05-26
MRW	4	2002-07-24
JDQ	4	1993-03-24
ODP	3	2016-03-02
OVE	3	2015-01-21
OVD	3	2012-07-26
JDN	3	1990-06-21
OUR	2	2016-08-12
MJO	2	2014-07-24
JEY	2	2011-04-13
HRS	2	1992-12-17
HWC	2	1988-05-25
PML	1	2020-08-19
PGM	1	2015-02-25
OSH	1	2013-06-05
HBE	1	2011-10-26
MJO	1	2007-07-16
FMF	1	2006-12-08
GEI	1	2006-09-05
MQV	1	2005-12-16
NVR	1	2005-09-09
NQW	1	2005-06-06
GAD	1	2005-02-23
ETN	1	2003-04-11
NEK	1	2002-07-02
MAX	1	2002-06-13
JDR	1	2001-10-01
JDI	1	2001-04-27
GWG	1	1998-03-18

PMN#

CRADLE, HOSPITAL BED CLOTHING
1989-06-15
WARSAW ORTHOPEDIC, INC.
TSRH SACRAL SPINAL SCREW
1989-04-06
WARSAW ORTHOPEDIC, INC.
TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
1989-04-06
WARSAW ORTHOPEDIC, INC.
TSRH H/M HOOK HOLDER W/ROD MOVER
1988-03-04
WARSAW ORTHOPEDIC, INC.
TSRH H/M HOOK HOLDER
1988-03-04
WARSAW ORTHOPEDIC, INC.
TSRH H/M TORQUE LIMITING WRENCH
1988-02-18
WARSAW ORTHOPEDIC, INC.
TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD
1988-02-18
WARSAW ORTHOPEDIC, INC.
SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA
1987-05-27
WARSAW ORTHOPEDIC, INC.
SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP
1987-05-27
WARSAW ORTHOPEDIC, INC.
WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM
1987-05-04
WARSAW ORTHOPEDIC, INC.
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
1987-03-13
WARSAW ORTHOPEDIC, INC.
SCHULTZ PHALANGEAL COMPONENT DRIVER
1987-03-13
WARSAW ORTHOPEDIC, INC.
SCHULTZ MP COMPONENT PUNCH
1987-03-13
WARSAW ORTHOPEDIC, INC.
SCHULTZ METACARPAL COMPONENT DRIVER
1987-03-13
WARSAW ORTHOPEDIC, INC.
WARSAW ORTHOPEDIC POINTED REAMER
1987-03-11
WARSAW ORTHOPEDIC, INC.
WARSAW ORTHOPEDIC I BONE PLATE
1987-03-09
WARSAW ORTHOPEDIC, INC.
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
1986-07-25
WARSAW ORTHOPEDIC, INC.
WARSAW ORTHOPEDIC BONE PLATE
1986-07-08
WARSAW ORTHOPEDIC, INC.
SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS
1986-02-11
WARSAW ORTHOPEDIC, INC.
SUPRACONDYLAR BONE PLATE
1985-06-28
WARSAW ORTHOPEDIC, INC.
INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
1985-05-22
WARSAW ORTHOPEDIC, INC.
FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
1985-05-22
WARSAW ORTHOPEDIC, INC.
PARTIALLY THREADED BONE FIX. PIN
1984-08-02
WARSAW ORTHOPEDIC, INC.
FIXATION STAPLE DRIVER/EXTRACTOR
1983-10-20
WARSAW ORTHOPEDIC, INC.