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Data / Medical devices / United States / Culver Tool & Engineering

Culver Tool & Engineering: FDA-registered device maker in Plymouth, IN, United States, 1 510(k) clearance

Culver Tool & Engineering is registered with the FDA (registration 3010047454) in Plymouth, IN, United States. It lists 66 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 7, 2017. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Culver Tool & Engineering
FDA registration number
3010047454
Address
1901 Walter Glaub Dr 2121 Walter Glaub Dr, Plymouth, IN, United States, 46563
Owner or operator
Culver Tool & Engineering LLC dba SpiTrex CTE (10043008)
Roles
Contract manufacturer, Contract sterilizer, Manufacturer
First device listed
January 18, 2013
Registered through
2026
Brand names listed
Ferris Smith Pitutiary Rongeur, Gibralt, Globus Medical, Globus Medical-Creo DLX Deformity Stabilization System, Harrier - SA, InCompass (Spinal Fixation System), LLIF AMP, Laminoplasty and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
AwlHWJ1Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Contract manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Contract manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Contract manufactureraccessdata.fda.gov
Device, Germicidal, UltravioletMKB2Contract manufactureraccessdata.fda.gov
Electromyograph, DiagnosticIKN2Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufactureraccessdata.fda.gov
Growing Rod SystemPGM2Contract manufactureraccessdata.fda.gov
Growing Rod System- Magnetic ActuationPGN2Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Contract manufactureraccessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOQG2Contract manufactureraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Contract manufactureraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Contract manufactureraccessdata.fda.gov
Orthopedic Augmented RealitySBF2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, MetalNQW2Contract manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufactureraccessdata.fda.gov
PasserHWQ1Contract manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Contract manufactureraccessdata.fda.gov
Peripheral Mechanical Thrombectomy With AspirationQEW2Contract manufactureraccessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-AlterableGXN2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Contract manufactureraccessdata.fda.gov
Posterior Metal/Polymer Spinal System, FusionNQP2Contract manufactureraccessdata.fda.gov
ProbeHXB1Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
Punch, Femoral NeckHWP1Contract manufactureraccessdata.fda.gov
RaspHTR1Contract manufactureraccessdata.fda.gov
ReamerHTO1Contract manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Contract manufactureraccessdata.fda.gov
RongeurHTX1Contract manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Contract manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Evoked ResponseGWF2Contract manufactureraccessdata.fda.gov
Stimulator, NerveETN2Contract manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Contract manufactureraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWUContract manufactureraccessdata.fda.gov
TampHXG1Contract manufactureraccessdata.fda.gov
Tap, BoneHWX1Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufactureraccessdata.fda.gov
WrenchHXC1Contract manufactureraccessdata.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
July 7, 2017K171448Hammertoe Correction SystemHWCSubstantially EquivalentLife Spine, Inc.accessdata.fda.gov

Compare with other makers

Updated July 7, 2017. 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.