FDA Registration
Active
🇺🇸 United States
TURNCO TOOL & INSTRUMENT, INC.
Reg #: 3009241418
·
FEI: 3009241418
·
Expires 2026
Products
42
Proprietary Names
215
Establishment Types
1
Classifications
42
Registration Details
- Registration Name
- TURNCO TOOL & INSTRUMENT, INC.
- Registration Number
- 3009241418
- FEI Number
- 3009241418
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5080 East State Highway 29
- City
- Georgetown
- State
- TX
- ZIP
- 78626
- Country
- US
Owner / Operator
- Firm Name
- Turnco Tool & Instrument, Inc.
- Operator Number
- 10042197
- Address
- 5080 East State Highway 29
- City
- Georgetown
- State
- TX
- Postal Code
- 78626
- Country
- US
- Correspondent
- Brandon Griffin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-03-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-03-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-03-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-03-20 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2014-12-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2018-09-18 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-09-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-09-18 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2014-03-20 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-03-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2023-05-11 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2015-11-25 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2020-12-07 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-02-11 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2015-03-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-11-25 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2016-10-06 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-12-08 |
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | Class 2 | Orthopedic | No | 2020-11-16 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-06-06 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2015-11-25 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2014-10-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2014-10-24 |
| Bender | HXW | Class 1 | Orthopedic | No | 2015-11-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-11-25 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2015-11-25 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2015-11-30 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-01-21 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2015-11-30 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2015-11-30 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2018-09-18 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-09-18 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2018-09-18 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2015-03-23 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2016-10-06 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2016-10-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-01-21 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2015-11-25 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2015-11-30 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2012-10-31 |
| Template | HWT | Class 1 | Orthopedic | No | 2015-11-25 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-02-11 |
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
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
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
DJO Surgical Hex Screw Driver
Foundation Revision Knee
InFill Intervertebral Body Fusion Device
XIPHOS ZFUZE PLIF Interbody Fusion System
Integra surgical instrument -Head sizing plate
Head Sizing Plates Size 42
Head Sizing Plates Size 50
Head Sizing Plates Size 38-E
Head Sizing Plates Size 40-E
Head Sizing Plates Size 48
Head Sizing Plates Size 52
Head Sizing Plates Size 44
Head Sizing Plates Size 46
Altivate Anatomic Humeral Head Trial Construct Extractor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)