TURNCO TOOL & INSTRUMENT, INC.

FDA Device Registration & Listing · Georgetown, TX, US · Registration 3009241418

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009241418
FEI Number
3009241418
Entity Name
TURNCO TOOL & INSTRUMENT, INC.
City/State/Country
Georgetown, TX, US
Establishment Address
5080 East State Highway 29, Georgetown, TX 78626, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Turnco Tool & Instrument, Inc. (Owner Number: 10042197)
Owner / Operator Contact Address
5080 East State Highway 29, Georgetown, TX 78626, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EXPRT Revision Hip, Taper Breaker Integra Surgical Instrument - Retractor Altivate Anatomic™ CS, Pin Guide Altivate Anatomic™ CS, Humeral Punch, Sz 3 Altivate Anatomic™ CS, Punch Inserter Handle Altivate Anatomic™ CS, Humeral Punch, Sz 2 Altivate Anatomic™ CS, Humeral Punch, Sz 1 EMPOWR PARTIAL KNEE Femoral Impactor EMPOWR PARTIAL KNEE Universal Tibial Handle EMPOWR PARTIAL KNEE Tibial Insert Impactor Phenix Integra surgical instrument - drill adaptor Integra surgical instrument - starter drill guide Lucent Ti-Bond Empowr Box Cut Guide Chisel SILICA MUH Head Polished Sz. 19 Movation Femoral Peg Lug DJO Surgical Femoral Sizer MIKA DJO Surgical Bone Screw Drill Guide MIKA Trochlear Drill Guide MIKA Alignment Tower DJO Surgical Anteror Cut Guide MIKA Small Tibal Broach Drill Guide DJO Surgical Osteotomy Guide DJO Surgical Tri-Peg Patella Trial Ultra-Congruent Tibial Insert Trial Size 12 11mm Ultra-Congruent Tibial Insert Trial Size 2 15mm Large Tibal Broach Drill Guide Ultra-Congruent Tibial Insert Trial Size 2 13mm Trial Shell, 68mm Acetabular FH Neck Trial, Size 12/13.5 DJO Surgical Anterior Cut Guide Ultra-Congruent Tibial Insert Trial Size 10 13mm DJO Surgical Open Box Cut Guide FH Neck Trial, Size 15/16.5/1 Trial Shell, 70mm Acetabular Encore Reverse Shoulder, Extramedullary Ostotomy Guide Ultra-Congruent Tibial Insert Trial Size 4 19mm Ultra-Congruent Tibial Insert Trial Size 6 19mm Ultra-Congruent Tibial Insert Trial Size 2 19mm Trochlear Drill Guide Type 2 Ultra-Congruent Tibial Insert Trial Size 6 13mm Tibial Size/Trial, Size 1R Tibial Sizer/Trial, Size10R Ultra-Congruent Tibial Insert Trial Size 2 9mm Ultra-Congruent Tibial Insert Trial Size 2 11mm Altivate Anatomic™ Humeral Drill Guide Lug Altivate Reverse, Hemi-Adapter Trial, Anatomic, Stem, Neutral Altivate Reverse, Hemi-Adapter Trial, Anatomic, Broach, Neutral DJO EMPOWR KNEE™ Anterior Femoral Peg Drill Guide Altivate Anatomic™ Humeral Planer Guide Pin Altivate Anatomic™ Humeral Head Trial Construct Extractor DJO EMPOWR KNEE™ Posterior Femoral Peg Drill Guide Altivate Reverse, Hemi-Adapter Trial, Anatomic, Broach, Offset Altivate Reverse, Hemi-Adapter Trial, Turon Altivate Reverse, Hemi-Adapter Trial, Anatomic, Stem, Offset Foundation Hip Neck Trial Ascension DRUJ Ascension© First Choice© DRUJ System Ulnar Implant 19mm head 5.5mm stem Ascension© First Choice© DRUJ System Ulnar Implant 16mm head 6.5mm stem Ascension© First Choice© DRUJ System Ulnar Implant 16mm head 5.5mm stem InFill TLIF Oblique Device MIKA Drill Bushing Integra surgical instrument - cement pressurizer Integra surgical instrument - proximal osteotomy guide Integra surgical instrument - anti rotation peg Integra surgical instrument - taper adapter Integra surgical instrument - distal osteotomy guide DJO Surgical Fixed Tibial Stylus DJO Surgical Fixed Stylus Quick Lock Handle HRA Trial Size 56-21 DJO Surgical Broach HRA Trial Size 52-18 DJO Surgical Humeral Broach Handle DJO Revision Tibial Cut Block DJO Surgical Glenoid Pressurizer CMRH Stem Trial Size 03 Integra surgical instrument - sizer alignment guide Encore Reverse Shoulder, Humeral Protector Small DJO Surgical Handle, Glenoid Pressurizer / Pusher DJO Surgical Keeled Glenoid Pressurizer Turon Proximal Humeral Protector DJO Surgical Femoral Shift Block Special Exprt Spacer Block Size 24mm Turon Impaction Fixture Integra TITAN Humeral Resurfacing Arthroplasty Instruments - HRA Adapter Special Exprt Spacer Block Size 31.5mm Special Exprt Spacer Block Size 26.5mm InFill Retractor Insertion Tool DJO Empowr Knee 2mm Femoral Shift Block CMRH Stem Trial Size 02 Empowr Distal FEM 2mm Recut Spacer Integra Surgical Instrument - Central Drill Integra Surgical Instrument - Retractor CMRH Stem Trial Size 01 Special Exprt Spacer Block Size 29mm Pop Stoma Blade Integra Surgical Instrument - Sizer/Centralizer Altivate Reverse, Humeral Shell Trial Guide Pin Integra Surgical Instrument - Drill Guide Encore Reverse Shoulder, Humeral Protector Large Integra© External Fixation System Provisional Midfoot Support Integra© External Fixation System Provisional Calf Support Cadence© Total Ankle System Size 1 Tibial-Right Integra® External Fixation System Provisional Calf Support Integra© External Fixation System Provisional Heel Support Integra© Surgical Instruments Slap Hammer Titan™ Total Shoulder System TSS Taper Adapter, 2.5 Integra® External Fixation System Provisional Heel Support Central Protection Sleeve, Diameter 9mm EMPOWR PARTIAL KNEE™ Universal Tibial Handle Altivate Reverse Revision Osteotome Talar Flat Cut, Drill Guide Threaded Axis Handle-Nail Fixation Bolt Internal Protection Sleeve, 3.2mm Diameter External Protection Sleeve, Diameter 13.5mm DJO EMPOWR KNEE™ Offset Patella Drill Guide_Large Talar Flat Cut Guide DJO EMPOWR KNEE™ Offset Patella Drill Guide_Small 2mm Talar Cut Guide MRH Head Trial, Size 205 X-ALT Medium Acetabular Liner Impactor Handle RSS Baseplate Boss Drill Guide-S Depth Gage Acetabular Liner Impactor, 20 Sombrero-44mm Acetabular Liner Impactor, 20 Sombrero-32mm Integra surgical instrument - distal impactor Acetabular Liner Impactor, Non-Hooded, Sombrero-44mm DJO Surgical Socket Impactor Acetabular Liner Impactor, 10 Sombrero-44mm DJO Surgical Acetabular Impactor Integra surgical instrument - metatarsal impactor Acetabular Liner Impactor, 20 Sombrero-40mm Acetabular Liner Impactor, Non-Hooded, Sombrero-36mm Acetabular Liner Impactor, Non-Hooded, Sombrero-28mm Acetabular Liner Impactor 20 Sombrero 28mm Acetabular Liner Impactor, 10 Sombrero-34mm DJO Surgical Impaction Fixture X-alt Acetabular Liner Imactor PIP Proximal Impactor Acetabular Liner Impactor, 20 Sombrero-34mm Acetabular Liner Impactor, 10 Sombrero-40mm Turon Impaction Fixture Acetabular Liner Impactor, 20 Sombrero-36mm Acetabular Liner Impactor, 10 Sombrero-36mm DJO Surgical Baseplate Impactor Integra surgical instrument - phalanx impactor Integra Surgical Instrument - Impactor Assembly Acetabular Liner Impactor, Non-Hooded, Sombrero-40mm Femoral Head Impactor Acetabular Liner Impactor 10 Sombrero 28mm EPIK Baseplate Impactor Acetabular Liner Impactor Non-Hooded Sombrero-32mm Acetabular Liner Impactor Non-Hooded Sombrero-34mm Acetabular Liner Impactor 10 Sombrero 32mm MCP Proximal Impactor Integra© First Choice© DRUJ System MUH Stem Impactor ACET Cup Trial Impactor, 1/4-28 Tip EMPOWR PARTIAL KNEE™ Femoral Impactor EMPOWR PARTIAL KNEE™ Tibial Insert Impactor Straight Acetabular Impactor, EMPOWR Knee 2 Alignment Pending Knee 2 Alignment Rod Modular Knee 2 Double Angel Wing Knee 2 Alignment Tower Rebel Spacer Blocks Unipolar Head Size 58 Unipolar BASALT OBSIDIAN MAGMA SLATE SMALL MAGMA EXPRT Straight Stem Trial DJO Surgical Humeral Planer Driver DJO Surgical Neck Extractor DJO Surgical Stem Extractor DJO Surgical Head Distractor XIPHOS InFill 43-TLIF Contour Oblique Emerald Cervical PEEK System Onyx PLIF Peek System Medical Concepts Interbody Fusion System Altivate Anatomic Turon Humeral Head Neck Adapter Altivate Anatomic Humeral Head Neck Adapter Altivate Anatomic Modular Head Trial Altivate Anatomic Drill Guide Handle EPIK Femur EPIK Knee Femur Machined Size 8 EPIK Knee Femur Machined Size 4 EPIK Knee Femur Machined Size 10 EPIK Knee Encore Reverse Shoulder, Reamer Infill Graft Delivery System Integra surgical instrument - distal broach RSP Humeral Broach Integra surgical instrument - distal cutting broach Integra Surgical Instrument - Starter Broach Integra surgical instrument - proximal cutting broach Integra Surgical Instrument - Proximal Broach

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-03-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-03-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-03-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-03-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-20
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2014-12-16
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-09-18
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-09-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-09-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2014-03-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-03-20
GAD Retractor General, Plastic Surgery Class 1 878.4800 2023-05-11
HWJ Awl Orthopedic Class 1 888.4540 2015-11-25
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2020-12-07
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-02-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-09-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-03-23
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-03-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2015-11-25
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-03-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-09-16
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2016-10-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-09-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-10-31
KXE Prosthesis, Wrist, Hemi-, Ulnar Orthopedic Class 2 888.3810 2020-11-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-06-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-10-24
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2015-11-25
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2014-10-24
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-10-24
KXE Prosthesis, Wrist, Hemi-, Ulnar Orthopedic Class 2 888.3810 2016-10-07
HXW Bender Orthopedic Class 1 888.4540 2015-11-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-03-20
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-11-25
HWA Impactor Orthopedic Class 1 888.4540 2015-11-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-11-30
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2015-11-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-10-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-10-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-09-16
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2013-01-21
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-10-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-10-07
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-09-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-09-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-03-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-03-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-09-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-06-06
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2015-11-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-10-31
HWB Extractor Orthopedic Class 1 888.4540 2015-11-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-09-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-09-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-10-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-10-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-12-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-12-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-06-07
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2018-09-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-09-18
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-09-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-21
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-03-23
HTO Reamer Orthopedic Class 1 888.4540 2016-10-06
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-10-10
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-01-21
HTQ Broach Orthopedic Class 1 888.4540 2015-11-25

Official Correspondent

Brandon Griffin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Turnco Tool & Instrument, 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
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
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009241418. Last updated year: 2026. Please use registration number 3009241418 when referencing this establishment in official correspondence.
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