FDA Registration
Active
🇺🇸 United States
MAITLAND ENGINEERING
Reg #: 1835572
·
FEI: 3001452082
·
Expires 2026
Products
57
Proprietary Names
50
Establishment Types
2
Classifications
57
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Registration Details
- Registration Name
- MAITLAND ENGINEERING
- Registration Number
- 1835572
- FEI Number
- 3001452082
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2713 Foundation Dr
- City
- South Bend
- State
- IN
- ZIP
- 46628
- Country
- US
Owner / Operator
- Firm Name
- Maitland Engineering
- Operator Number
- 10042537
- Address
- 2713 Foundation Drive
- City
- South Bend
- State
- IN
- Postal Code
- 46628
- Country
- US
- Correspondent
- Scott M Beehler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-01-30 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-06-20 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2018-06-20 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2018-06-20 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-11-14 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-11-14 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-09-18 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2020-09-18 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-06-18 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-12-06 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-06-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-09-01 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-11-09 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-06-15 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-11-09 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-11-09 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2026-05-07 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2020-04-29 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2017-06-05 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-01-28 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-25 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-01-28 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-25 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-03-16 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-03-16 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2023-04-21 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-25 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2020-01-07 |
| Fork | HXE | Class 1 | Orthopedic | No | 2013-01-25 |
| Template | HWT | Class 1 | Orthopedic | No | 2024-11-07 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2023-04-21 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-01-25 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-11-02 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-11-02 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-11-02 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-04-21 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2013-01-31 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2018-08-17 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2018-09-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-11-07 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2020-09-02 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2018-08-17 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2018-09-12 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-05-08 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-01-25 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2018-11-09 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2018-11-14 |
Proprietary Names
TM REVERSE 2.5MM PIN STERTM REVERSE 2.5MM PIN STER
HWC-Screw, fixation, bone HRS- Plate, fixation bone
TRANSFX External Fixation
Bead Tip Guidewire 2.6MM x 80CM
CAS Fix Fluted
TM REVERSE 2.5MM PIN
TM REVERSE 2.5MM STERILE
Freedom PRV
Rod, Fixation, Intramedullary and Accessories
Orthopedic Manual Surgical Instrument
Periarticular Locking Plate System
Threaded Fixation Pin
Bit, Drill
Comprehensive Non-Locking Screw 110003496
Comprehensive Locking Screw 110003498
Comprehensive Reverse Shoulder
MicroAire Kirschner Wires
MicroAire Steinmann Pins
ALthread PEEK Suture Anchor
Plate Fixation
Tap
Knowles Pins
T7 DRIVER SOLID AO 11003866200
T7 DRIVER CANN AO 11003866100
G7 Dual Mobility System
Comprehensive Shoulder
902813-00 Knot Pusher Assembly
ALLThread Anchors
Zimmer Biomet
Comprehensive Shoulder System
903610-00 Suture Crocket Hook
ROSA CHECKPOINT SCREW 17MM STR 20-8020-160-00
ROSA CHECKPOINT SCREW 15MM STR 20-8020-159-00
ROSA CHECKPOINT SCREW 13MM STR 20-8020-158-00
Persona Revision Knee System
904100-00 Graft Prep Table
Trephine
Screw
Distal Trocar 3.2MM,3.7MM,5MM
Fem AWL 7MM
Slotted Mallot
903721-00 3.2MM Guide Pin Hand
ZCAS ROSA Screw 15 MM
ZCAS ROSA Screw 13 MM
ZCAS ROSA Screw 17 MM
5MM Cortical Screw
JDW - PIN, FIXATION, THREADED
TM GLENOID PIN 2.5MM x 150MM
Wrench
LXT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device