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Data / Medical devices / United States / Precision Spine, Inc.

Precision Spine, Inc.: FDA-registered device maker in Pearl, MS, United States, 49 510(k) clearances

Precision Spine, Inc. is registered with the FDA (registration 3005739886) in Pearl, MS, United States. It lists 48 device types. The FDA files 49 510(k) clearances under its listings, the newest dated November 24, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Precision Spine, Inc.
FDA registration number
3005739886
Address
2050 Executive Dr, Pearl, MS, United States, 39208
Owner or operator
Spinal USA, Inc. (9087328)
Roles
Manufacturer
First device listed
May 18, 2006
Registered through
2026
Brand names listed
ACCUFIT ALIF PLATE SYSTEM, ACCUFIT LATERAL 2-HOLE PLATE SYSTEM, ACCUFIT LATERAL PLATE SYSTEM, ACCUFIT RP SYSTEM, DAKOTA ACDF SYSTEM, DAKOTA ALIF PLATE SYSTEM, DAKOTA ALIF SYSTEM, DAKOTA LP ACIF SYSTEM and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Manufactureraccessdata.fda.gov
ElevatorHTE1Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
ForkHXE1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Manufactureraccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Prosthesis, Hip, Cement RestrictorJDK2Manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Spinous Process PlatePEK2Manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufactureraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWUManufactureraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 24, 2025K250769Dakota LP SystemODPSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
December 17, 2024K242297Reform Pedicle Screw SystemNKBSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
May 25, 2023K231229S-COMP Reform® POCT Navigation InstrumentsOLOSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
July 14, 2022K220862E-GPS Navigated InstrumentsOLOSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
April 1, 2022K213118Dakota ALIF SystemOVDSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
March 16, 2022K220324AccuFit Lateral 2-Hole PlateKWQSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
December 8, 2021K212075ShurFit Lumbar Interbody SystemMAXSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
November 4, 2021K212937Dakota ALIF Plate SystemKWQSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
January 12, 2021K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemOVESubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
May 19, 2020K200303Reform Pedicle Screw SystemNKBSubstantially EquivalentPrecision Spineaccessdata.fda.gov
October 29, 2019K192494NexGen Anterior Cervical Plate SystemKWQSubstantially EquivalentPrecision Spineaccessdata.fda.gov
September 27, 2019K181606Precision Spine Navigation InstrumentationOLOSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
April 11, 2018K172495Reform® POCT SystemNKGSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
December 19, 2017K173130Reform® Midline Cortical Screw SystemNKBSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
August 11, 2017K171657ShurFit 2C Lumbar Interbody Fusion SystemMAXSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
December 6, 2016K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemODPSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
November 28, 2016K162211AccuFit Lateral Plate SystemKWQSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
November 22, 2016K162300Reform® POCT SystemNKGSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
May 4, 2016K160568Precision Spine Interspinous Plate SystemPEKSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
August 21, 2015K151422Reform Pedicle Screw SystemNKBSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
August 7, 2015K151863Precision Spine Interspinous Plate SystemPEKSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
July 7, 2015K150856Reform Pedicle Screw SystemNKBSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
June 4, 2015K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWPSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
December 19, 2014K143248Reform Pedicle Screw SystemNKBSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
December 18, 2014K142378Interspinous Plate SystemPEKSubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
June 26, 2014K141397SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEMMNISubstantially EquivalentPrecision Spine, Inc.accessdata.fda.gov
November 25, 2013K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICEOVESubstantially EquivalentSpinal USAaccessdata.fda.gov
August 9, 2013K130863FACET SCREW SYSTEMMRWSubstantially EquivalentSpinal USAaccessdata.fda.gov
July 24, 2013K131343REFORM PEDICLE SCREW SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
June 20, 2013K130279REFORM PEDICLE SCREW SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
April 25, 2013K130445VAULT ALIF SYSTEMOVDSubstantially EquivalentSpinal USAaccessdata.fda.gov
November 20, 2012K122931S-LOK PSS SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
August 8, 2012K121172REFORM PEDICLE SCREW SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
July 11, 2012K112748SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentSpinal USA, LLCaccessdata.fda.gov
September 15, 2011K112025SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEMKWPSubstantially EquivalentSpinal USAaccessdata.fda.gov
April 4, 2011K103369VAULT ALIF SYSTEMOVDSubstantially EquivalentSpinal USAaccessdata.fda.gov
November 17, 2009K092659SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25KWQSubstantially EquivalentSpinal USAaccessdata.fda.gov
September 25, 2009K092193SPINAL USA INTERBODY CAGESMAXSubstantially EquivalentSpinal USAaccessdata.fda.gov
September 14, 2009K092128MODIFICATION TO: PSS SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
July 9, 2009K091044SPINAL USA ANTERIOR LUMBAR PLATE SYSTEMKWQSubstantially EquivalentSpinal USAaccessdata.fda.gov
May 27, 2009K083118SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICEODPSubstantially EquivalentSpinal USAaccessdata.fda.gov
May 6, 2009K090033MODIFICATION TO: PSS SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
October 16, 2008K081196SPINAL USA VBR SYSTEMMAXSubstantially EquivalentSpinal USAaccessdata.fda.gov
May 13, 2008K080314SPINAL USA INTERBODY FUSION DEVICEMAXSubstantially EquivalentSpinal USAaccessdata.fda.gov
March 20, 2008K073240PSS SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
September 19, 2007K070922MODIFICATION TO SPINAL USA VBR SYSTEMKWQSubstantially EquivalentSpinal USAaccessdata.fda.gov
August 21, 2007K071438PSS SYSTEMMNISubstantially EquivalentSpinal USAaccessdata.fda.gov
April 18, 2006K060025SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentSpinal USAaccessdata.fda.gov
March 16, 2006K060132SPINAL USA CEMENT RESTRICTOR SYSTEMJDKSubstantially EquivalentSpinal USAaccessdata.fda.gov

Compare with other makers

Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.