OSSEUS FUSION SYSTEMS LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010531060	3010531060	OSSEUS FUSION SYSTEMS LLC	1	N	2026-01-01	1931 Greenville Avenue Suite 200 Dallas TX US 75206

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
B06221003154	White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 54mm, CANN, PREF ACP	888-330-5960	Info@osseus.com
B06221003157	White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 57mm, CANN, PREF ACP	888-330-5960	Info@osseus.com
B0622100316	White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x16mm, DBL LEAD, PREF ACP	888-330-5960	Info@osseus.com
B06221003160	White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 60mm, CANN, PREF ACP	888-330-5960	Info@osseus.com
B06221003163	White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 63mm, CANN, PREF ACP	888-330-5960	Info@osseus.com
B06221003166	White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 66mm, CANN, PREF ACP	888-330-5960	Info@osseus.com
B06221003169	White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 69mm, CANN, PREF ACP	888-330-5960	Info@osseus.com

osseus.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
163983	1307742056	K222107	Black Diamond™ POCT Spinal System	NKG	2022-11-03
163983	1821048455	K213935	PISCES-SA Standalone ALIF Interbody System	OVD	2022-05-06
163983	1499627656	K213590	Blue Topaz Sacroiliac Screw System	OUR	2022-03-01
163983	1754520402	K192495	Black Diamond Navigation Instruments	OLO	2020-01-17
163983	1018249322	K192121	Black Diamond Pedicle Screw System	NKB	2019-10-29
163983	1678353354	K181881	Outlet Sacroiliac Joint Fusion System	OUR	2018-10-03
163983	1929863423	K181347	Aries® Lumbar Interbodies	MAX	2018-08-15
163983	1464625007	K170844	Gemini-C Hybrid Cervical Interbody System	ODP	2017-07-03
163983	2023239115	K160522	White Pearl Preferred Angle Anterior Cervical Plate	KWQ	2016-04-26
163983	1590266329	K131810	OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM	MNH	2013-08-08
163983	1050605366
163983	1053723355
163983	1057015072
163983	1102654681
163983	1155882589
163983	1212467012
163983	1221300556
163983	1320883130
163983	1485787803
163983	1519051754
163983	1620587424
163983	1621770648
163983	1632017673
163983	1633989725
163983	1655562194
163983	1695158558
163983	1701399396
163983	1794106336
163983	1802131824
163983	1864586274
163983	1911260584
163983	1918601293
163983	1967221744
163983	1969753282
163983	2031513635

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OUR	2	2022-03-01
NKG	1	2022-11-03
OVD	1	2022-05-06
OLO	1	2020-01-17
NKB	1	2019-10-29
MAX	1	2018-08-15
ODP	1	2017-07-03
KWQ	1	2016-04-26
MNH	1	2013-08-08

PMN#

Pisces?-SA STANDALONE ALIF Interbody System

2023-02-10

Osseus Fusion Systems

Black Diamond™ POCT Spinal System

2022-11-03

Osseus Fusion Systems

PISCES-SA Standalone ALIF Interbody System

2022-05-06

Osseus Fusion Systems

Blue Topaz Sacroiliac Screw System

2022-03-01

Osseus Fusion Systems, LLC

Black Diamond Navigation Instruments

2020-01-17

Osseus Fusion Systems

Black Diamond Pedicle Screw System

2019-10-29

Osseus Fusion Systems

Aries® Lumbar Interbodies

2018-08-15

Osseus Fusion Systems, LLC

Gemini-C Hybrid Cervical Interbody System

2017-07-03

Osseus Fusion Systems, LLC

White Pearl Preferred Angle Anterior Cervical Plate

2016-04-26

OSSEUS FUSION SYSTEMS, LLC

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM

2013-08-08

OSSEUS FUSION SYSTEMS, LLC

GUDID#

Aries-L Lateral Lumbar Interbody System - 20x40x16, 8 degree, LLIF

Osseus Fusion Systems, LLC

2020-05-01

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 69mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 66mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 63mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 60mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x16mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 57mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 54mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 51mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 48mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 45mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 42mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x14mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 39mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 36mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 3-LEVEL, 34mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x12mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-TAPPING, 3.75x10mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, FIXED, SELF-DRILLING, 3.75x20mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, FIXED, SELF-DRILLING, 3.75x18mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, FIXED, SELF-DRILLING, 3.75x16mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 46mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 43mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 40mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, FIXED, SELF-DRILLING, 3.75x14mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 37mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 34mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 32mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 30mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 28mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 26mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 24mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 22mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - WHT PEARL CERV PLATE, 2-LEVEL, 20mm, CANN, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, FIXED, SELF-DRILLING, 3.75x12mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, FIXED, SELF-DRILLING, 3.75x10mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x20mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x18mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x16mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

White Pearl Preferred Angle ACP - CERV SCREW, VARIABLE, SELF-DRILLING, 3.75x14mm, DBL LEAD, PREF ACP

Osseus Fusion Systems, LLC

2017-01-11

200 records. Showing 1-40. Next