Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1835572

FEI Number

3001452082

Entity Name

MAITLAND ENGINEERING

City/State/Country

South Bend, IN, US

Establishment Address

2713 Foundation Dr, South Bend, IN 46628, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Maitland Engineering (Owner Number: 10042537)

Owner / Operator Contact Address

2713 Foundation Drive, South Bend, IN 46628, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 CAS Fix Fluted 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 Rod, Fixation, Intramedullary and Accessories MicroAire Kirschner Wires MicroAire Steinmann Pins ALthread PEEK Suture Anchor Plate Fixation Periarticular Locking Plate System Tap Knowles Pins T7 DRIVER SOLID AO 11003866200 T7 DRIVER CANN AO 11003866100 Periarticular Locking Plate System Rod, Fixation, Intramedullary and Accessories G7 Dual Mobility System Comprehensive Shoulder 902813-00 Knot Pusher Assembly Rod, Fixation, Intramedullary and Accessories CAS Fix Fluted ALLThread Anchors CAS Fix Fluted CAS Fix Fluted Periarticular Locking Plate System 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-01-30
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-06-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-06-20
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-06-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-14
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-09-18
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2020-09-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-06-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-12-06
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-12-02
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2013-01-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-06-15
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-06-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-06-20
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-06-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-09-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-09
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-06-15
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-11-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-04-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2018-11-09
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2018-11-09
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2018-11-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2026-05-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-05-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-05-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-09-12
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2012-12-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-04-29
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-06-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-04-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-25
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-25
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-01-28
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-25
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-01-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-28
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2015-08-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-08-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-08-31
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2018-04-05
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-03-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-04-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-03-16
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-03-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-03-16
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2021-03-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-10
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-01-10
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2023-04-21
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-03-04
HXW	Bender	Orthopedic	Class 1	888.4540	2013-01-25
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-06-15
HWP	Punch, Femoral Neck	Orthopedic	Class 1	888.4540	2020-01-07
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-09-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-30
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-06-15
HXE	Fork	Orthopedic	Class 1	888.4540	2013-01-25
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-06-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-04-23
HWT	Template	Orthopedic	Class 1	888.4800	2024-11-07
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-03-28
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-03-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-03-28
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-04-21
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-01-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-11-30
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-25
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-11-02
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-11-02
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-11-02
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2023-04-21
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2013-01-31

Official Correspondent

Scott Beehler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Maitland Engineering

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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835572. Last updated year: 2026. Please use registration number 1835572 when referencing this establishment in official correspondence.