Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010531060

FEI Number

3010531060

Entity Name

OSSEUS FUSION SYSTEMS LLC

City/State/Country

Dallas, TX, US

Establishment Address

1931 Greenville Avenue, Suite 200, Dallas, TX 75206, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OSSEUS FUSION SYSTEMS LLC (Owner Number: 10045353)

Owner / Operator Contact Address

1931 Greenville Avenue, suite 200, Dallas, TX 75206, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Black Diamond POCT Quick Connect Ratchet Handle RATCHET HANDLE, PREF ACP Rod Persuader PLATE BENDER, PREF ACP White Pearl ACP Cervical Plate Gemini-C interbody WIRE INTRODUCER, PREF ACP LLIF Inserter Aries Lumbar Interbody K-wire DRILL GUIDE, PREF ACP Instrument tray PISCES-SA ALIF Interbody Black Diamond Stereotaxic Instruments Rod Pusher FIXATION PIN, PREF ACP Rod Rocker FIXATION PIN INSERTER, PREF ACP FIXATION SCREW, PREF ACP LOCKING DRIVER, PREF ACP Rod Passer Driver GUIDE WIRE, PREF ACP Rod Holder Gemini-C Inserter Gemini-C Trial Black Diamond PSS 13X50MM IMPLANT 3.2MM STEINMANN PIN, SHARP 13MM WASHER 13X60MM IMPLANT 13X45MM IMPLANT 11X60MM IMPLANT 11MM WASHER 11X55MM IMPLANT 13X35MM IMPLANT 11X50MM IMPLANT 11X40MM IMPLANT 11X35MM IMPLANT Blue Topaz CompreSIve Sacroiliac Screw System 3.2MM STEINMANN PIN, ROUND 13X40MM IMPLANT 11MM DRILL, CANNULATED 11X45MM IMPLANT 13X55MM IMPLANT Compressor Distractor Bone Probe Bone Tap TAP, PREF ACP Gemini-C tamp LLIF STRAIGHT TAMP, ARIES-L Screw Tab Breaker Pedicle Bone Deburrer Gemini-C Rasp LATERAL RASP, ARIES L Rod Passer Screw Driver SCREW INSERTER, PREF ACP awl AWL, PREF ACP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2023-01-30
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-11-07
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2018-12-20
HTX	Rongeur	Orthopedic	Class 1	888.4540	2018-12-20
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2013-11-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-05-06
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-12-18
HXN	Applier, Cerclage	Orthopedic	Class 1	888.4540	2017-01-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-12-20
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-11-07
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-11-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-11-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-11-07
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-05-10
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2022-05-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-05-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-01-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-11-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-09
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2019-07-18
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2013-11-07
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-11-07
HXB	Probe	Orthopedic	Class 1	888.4540	2013-11-07
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-11-07
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2018-12-20
HTO	Reamer	Orthopedic	Class 1	888.4540	2018-12-20
HXG	Tamp	Orthopedic	Class 1	888.4540	2017-12-18
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2013-11-07
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-11-07
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-11-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-11-07
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSSEUS FUSION SYSTEMS LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161478	Xenco Medical, LLC	Xenco Medical Posterior Cervical System	2016-09-06
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010531060. Last updated year: 2026. Please use registration number 3010531060 when referencing this establishment in official correspondence.