Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005739886

FEI Number

3005739886

Entity Name

Precision Spine, Inc.

City/State/Country

Pearl, MS, US

Establishment Address

2050 Executive Dr, Pearl, MS 39208, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spinal USA, Inc. (Owner Number: 9087328)

Owner / Operator Contact Address

2050 Executive Drive, --, Pearl, MS 39208, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092193

PMA Number

N/A

All Registered Proprietary Names

PRECISION SPINE NAVIGATION INSTRUMENTATION SHURFIT LUMBAR MD-VUE LATERAL DISCECTOMY SYSTEM ACCUFIT LATERAL PLATE SYSTEM ACCUFIT ALIF PLATE SYSTEM SHURFIT INTERBODY DEVICE SYSTEM DAKOTA ALIF SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM VAULT ALIF SYSTEM SHURFIT INTERBODY DEVICE SYSTEM SHURFIT LUMBAR VAULT C ACDF SYSTEM SHURFIT INTERBODY DEVICE SYSTEM SURELOK PSS SYSTEM SURELOK PC SYSTEM SLIMPLICITY ACP SYSTEM REFORM POCT SYSTEM SURELOK PSS SYSTEM FACET SCREW SYSTEM RCS BUTTRESS PLATE SLIMPLICITY ACP SYSTEM VAULT C ACDF SYSTEM DAKOTA ACDF SYSTEM REFORM PSS SYSTEM ACCUFIT RP SYSTEM MD-VUE LATERAL ACCESS SYSTEM ACCUFIT ALIF PLATE SYSTEM SURELOK PC SYSTEM VAULT ALIF SYSTEM ACCUFIT LATERAL PLATE SYSTEM RELI SP SPINOUS PLATING SYSTEM REFORM POCT SYSTEM SHURFIT ACIF SYSTEM REFORM POCT SYSTEM ACCUFIT LATERAL PLATE SYSTEM RCS BUTTRESS PLATE SHURFIT INTERBODY DEVICE SYSTEM DAKOTA ALIF SYSTEM SHURFIT LUMBAR DAKOTA ACDF SYSTEM DAKOTA ACDF SYSTEM RELI SP SPINOUS PLATING SYSTEM SURELOK PSS SYSTEM REFORM POCT SYSTEM VAULT C ACDF SYSTEM VAULT ALIF SYSTEM SLIMPLICITY ACP SYSTEM RCS BUTTRESS PLATE ACCUFIT RP SYSTEM REFORM PSS SYSTEM SURELOK PC SYSTEM ACCUFIT ALIF PLATE SYSTEM ACCUFIT LATERAL PLATE SYSTEM SLIMPLICITY ACP SYSTEM SURELOK PSS SYSTEM DAKOTA ACDF SYSTEM ACCUFIT RP SYSTEM RCS BUTTRESS PLATE VAULT C ACDF SYSTEM FACET SCREW SYSTEM ACCUFIT LATERAL PLATE SYSTEM ACCUFIT ALIF PLATE SYSTEM REFORM POCT SYSTEM REFORM PSS SYSTEM SURELOK PC SYSTEM SHURFIT INTERBODY DEVICE SYSTEM MD-VUE LATERAL ACCESS SYSTEM RELI SP SPINOUS PLATING SYSTEM SHURFIT ACIF SYSTEM VAULT ALIF SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM DAKOTA ALIF SYSTEM SHURFIT LUMBAR DAKOTA ALIF SYSTEM VAULT ALIF SYSTEM REFORM POCT SYSTEM REFORM PSS SYSTEM SURELOK PC SYSTEM SHURFIT INTERBODY DEVICE SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM MD-VUE LATERAL ACCESS SYSTEM SURELOK PSS SYSTEM SHURFIT LUMBAR SHURFIT ACIF 2C SYSTEM MD-VUE LATERAL ACCESS SYSTEM SURELOK PSS SYSTEM FACET SCREW REFORM POCT SYSTEM REFORM PSS SYSTEM VAULT C ACDF SYSTEM SURELOK PSS SYSTEM REFORM PSS SYSTEM DAKOTA ALIF SYSTEM SURELOK PSS SYSTEM RELI SP SPINOUS PLATING SYSTEM ACCUFIT ALIF PLATE SYSTEM SLIMPLICITY HP ANTERIOR CERVICAL PLATE SYSTEM NEXGEN ANTERIOR CERVICAL PLATE SYSTEM REFORM PSS SYSTEM REFORM POCT SYSTEM SHURFIT INTERBODY DEVICE SYSTEM SHURFIT INTERBODY DEVICE SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM SHURFIT LUMBAR VAULT ALIF SYSTEM REFORM TI MODULAR FACET SCREW SYSTEM SURELOK PC SYSTEM SURELOK PSS SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM REFORM POCT SYSTEM REFORM POCT SYSTEM SURELOK PSS SYSTEM REFORM PSS SYSTEM FACET SCREW SYSTEM SLIMPLICITY ACP SYSTEM SURELOK PC SYSTEM REFORM PSS SYSTEM DAKOTA ACDF SYSTEM REFORM POCT SYSTEM SURELOK PSS SYSTEM VAULT C ACDF SYSTEM RELI SP SPINOUS PLATING SYSTEM SURELOK PC SYSTEM RCS BUTTRESS PLATE REFORM POCT SYSTEM SHURFIT INTERBODY DEVICE SYSTEM REFORM PSS SYSTEM SURELOK PSS SYSTEM SHURFIT INTERBODY DEVICE SYSTEM SHURFIT ACIF SYSTEM DAKOTA ACDF SYSTEM VAULT C ACDF SYSTEM SHURFIT LUMBAR DAKOTA ALIF SYSTEM SLIMPLICITY ACP SYSTEM DAKOTA LP ACIF SYSTEM SURELOK PSS SYSTEM REFORM POCT SYSTEM REFORM PSS SYSTEM SURELOK PSS SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM SHURFIT INTERBODY DEVICE SYSTEM SHURFIT ACIF SYSTEM VAULT C ACDF SYSTEM SHURFIT LUMBAR RELI SP SPINOUS PLATING SYSTEM ACCUFIT ALIF PLATE SYSTEM REFORM PSS SYSTEM SHURFIT ACIF 2C SYSTEM SHURFIT 2C LUMBAR SYSTEM VBR System REFORM HA COATED PEDICLE SCREW SYSTEM SURELOK PC SYSTEM REFORM POCT SYSTEM REFORM PSS SYSTEM SURELOK PSS SYSTEM AccuFit Lateral 2-Hole Plate DAKOTA ALIF REFORM MIDLINE CORTICAL SYSTEM MD-VUE LATERAL ACCESS SYSTEM REFORM PSS SYSTEM REFORM PEDICLE SCREW SYSTEM SLIMPLICITY SOLO ACP SYSTEM RELI SP SPINOUS PLATING SYSTEM SURELOK PSS SYSTEM SHURFIT LUMBAR SURELOK PSS SYSTEM REFORM PSS SYSTEM MODIFICATION TO: SURELOK PSS SYSTEM DAKOTA ALIF SYSTEM SHURFIT LUMBAR SHURFIT INTERBODY DEVICE SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM SURELOK PSS SYSTEM - SLC EXTENDED TAB Dakota ALIF System SURELOK PC SYSTEM SHURFIT INTERBODY DEVICE SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM REFORM PSS SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM REFORM POCT SYSTEM SHURFIT INTERBODY DEVICE SYSTEM REFORM PSS SYSTEM DAKOTA ALIF SYSTEM SHURFIT LUMBAR VAULT ALIF SYSTEM SHURFIT INTERBODY DEVICE SYSTEM RELI SP SPINOUS PLATING SYSTEM VAULT C ACDF SYSTEM REFORM POCT SYSTEM DAKOTA ACDF SYSTEM REFORM PSS SYSTEM MD-VUE LATERAL DISCECTOMY SYSTEM SHURFIT ACIF SYSTEM SURELOK PSS SYSTEM SURELOK PC DAKOTA ALIF SYSTEM SLIMPLICITY ACP SYSTEM SURELOK PSS SYSTEM ACCUFIT ALIF PLATE SYSTEM ACCUFIT LATERAL PLATE SYSTEM RELI SP SPINOUS PLATING SYSTEM REFORM PSS SYSTEM REFORM POCT SYSTEM SURELOK PC SYSTEM SURELOK PSS SYSTEM SHURFIT INTERBODY DEVICE SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-11-08
HTX	Rongeur	Orthopedic	Class 1	888.4540	2013-08-01
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-06-29
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2014-08-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2009-10-07
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-06-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-07-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2009-10-07
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2017-01-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-01-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-01-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-05
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-08-01
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-01-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-01-19
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-07-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-08-01
HWB	Extractor	Orthopedic	Class 1	888.4540	2018-07-02
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-01-04
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2018-07-02
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2018-07-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2007-10-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2007-10-19
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2016-01-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2007-10-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-11-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-05-18
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2018-05-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-03-05
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-03-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-05
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-07-02
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2011-04-08
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-01-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-02
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2014-08-21
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-08-01
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-08-01
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-08-01
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2013-08-01
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-08-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2006-05-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-28
KTZ	Caliper	Orthopedic	Class 1	888.4150	2018-07-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2018-05-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2018-05-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-05-18
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-08-01
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2016-01-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2009-10-07
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-01-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-01-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-01-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-01-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-01-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-01-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2007-10-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-01-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-01-24
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-01-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-01-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-01-24
HXB	Probe	Orthopedic	Class 1	888.4540	2013-07-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-04-11
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-12-10
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-01-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-06-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-06-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-06-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-05
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2016-11-14
HXE	Fork	Orthopedic	Class 1	888.4540	2018-07-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-12-10
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-08-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-08-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-08-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-05
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-08-01
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-08-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-08-21
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-07-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-07-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-05
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2021-10-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-01-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-01-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-01-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-01-24
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-01-24
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2013-08-01
HWT	Template	Orthopedic	Class 1	888.4800	2013-08-01
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2018-06-07
HXW	Bender	Orthopedic	Class 1	888.4540	2013-07-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-03-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-05

Official Correspondent

Michael Dawson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spinal USA, Inc.

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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3020983478	ORTHOKEY ITALIA SRL	Firenze, IT
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005739886. Last updated year: 2026. Please use registration number 3005739886 when referencing this establishment in official correspondence.