CULVER TOOL & ENGINEERING

Contract manufacturer and sterilizer · Plymouth, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration: 3010047454 (openFDA record; or search FDA's registration database)
FEI number: 3010047454
Registered for: FDA registration year 2026
Establishment types: Manufacturer; Contract manufacturer; Contract sterilizer
Owner or operator: Culver Tool & Engineering LLC dba SpiTrex CTE (FDA owner/operator no. 10043008)
Registered address: 1901 Walter Glaub Dr, 2121 Walter Glaub Dr, Plymouth, IN 46563
Contract listings: 280 device listings, 66 product codes, first listed Jan 18, 2013
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
ETN	Stimulator, Nerve	Class II	Ear, nose and throat	Contract manufacturing	Nov 17, 2015
FLL	Continuous Measurement Thermometer	Class II	General hospital	Contract manufacturing	Mar 19, 2022
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jul 21, 2017
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jul 22, 2026
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 9, 2024
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Feb 23, 2017
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract manufacturing	Jul 21, 2017
GWF	Stimulator, Electrical, Evoked Response	Class II	Neurology	Contract manufacturing	Nov 17, 2015
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Class II	Neurology	Contract manufacturing	Dec 11, 2017
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Nov 17, 2015
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	May 18, 2020
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	May 18, 2020
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Mar 19, 2022
HTO	Reamer	Class I	Orthopedic	Contract manufacturing	Jan 29, 2013
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Mar 1, 2017
HTX	Rongeur	Class I	Orthopedic	Contract manufacturing	Mar 1, 2017
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	May 18, 2020
HWD	Starter, Bone Screw	Class I	Orthopedic	Contract manufacturing	Jul 21, 2017
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Jun 19, 2017
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Mar 1, 2017
HWP	Punch, Femoral Neck	Class I	Orthopedic	Contract manufacturing	Jul 21, 2017
HWQ	Passer	Class I	Orthopedic	Contract manufacturing	Jul 21, 2017
HWT	Template	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Mar 1, 2017
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Mar 1, 2017
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXG	Tamp	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
IKN	Electromyograph, Diagnostic	Class II	Physical medicine	Contract manufacturing	Nov 17, 2015
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
KRA	Catheter, Continuous Flush	Class II	Cardiovascular	Contract manufacturing	Mar 19, 2022
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract sterilization	Dec 2, 2016
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Jan 24, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Nov 25, 2015
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Jul 21, 2017
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
MKB	Device, Germicidal, Ultraviolet	Class II	General hospital	Contract manufacturing	Jan 9, 2019
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Dec 16, 2013
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Dec 4, 2014
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
NQP	Posterior Metal/Polymer Spinal System, Fusion	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Nov 17, 2015
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Nov 25, 2015
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 9, 2013
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Dec 2, 2016
PDQ	Neurosurgical Nerve Locator	Class II	Ear, nose and throat	Contract manufacturing	Nov 17, 2015
PGM	Growing Rod System	Class II	Orthopedic	Contract manufacturing	Mar 19, 2022
PGN	Growing Rod System- Magnetic Actuation	Class II	Orthopedic	Contract manufacturing	Dec 11, 2017
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Jan 9, 2019
PLR	Spinal Vertebral Body Replacement Device - Cervical	Class II	Orthopedic	Contract manufacturing	Jan 9, 2019
PML	Bone Cement, Posterior Screw Augmentation	Class II	Orthopedic	Contract manufacturing	Aug 6, 2026
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Class II	Cardiovascular	Contract manufacturing	Mar 19, 2022
SBF	Orthopedic Augmented Reality	Class II	Neurology	Contract manufacturing	Mar 19, 2022