MAITLAND ENGINEERING

Contract manufacturer · South Bend, IN

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

2012Product codes first listed, by year (tallest: 22)2026

FDA registration: 1835572 (openFDA record; or search FDA's registration database)
FEI number: 3001452082
Registered for: FDA registration year 2026
Establishment types: Manufacturer; Contract manufacturer
Owner or operator: Maitland Engineering (FDA owner/operator no. 10042537)
Registered address: 2713 Foundation Dr, South Bend, IN 46628
Contract listings: 69 device listings, 55 product codes, first listed Dec 6, 2012
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
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
GAH	Stylet, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
GDF	Guide, Needle, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
GDG	Hook, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Apr 21, 2023
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Jun 5, 2017
GEC	Brush, Scrub, Operating-Room	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jun 15, 2021
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 20, 2013
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Sep 12, 2018
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Jun 20, 2018
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 25, 2013
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Nov 9, 2018
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract manufacturing	Dec 11, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 20, 2013
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Nov 9, 2018
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Aug 17, 2018
HWK	Trephine	Class I	Orthopedic	Contract manufacturing	Aug 17, 2018
HWN	Instrument, Compression	Class I	Orthopedic	Contract manufacturing	Sep 12, 2018
HWP	Punch, Femoral Neck	Class I	Orthopedic	Contract manufacturing	Jan 7, 2020
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Nov 9, 2018
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Apr 21, 2023
HXE	Fork	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXI	Passer, Wire, Orthopedic	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HXL	Mallet	Class I	General and plastic surgery	Contract manufacturing	Sep 12, 2018
HXO	Pusher, Socket	Class I	Orthopedic	Contract manufacturing	Apr 21, 2023
HXW	Bender	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract manufacturing	Jan 30, 2013
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Nov 2, 2018
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Sep 18, 2020
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract manufacturing	Sep 2, 2020
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Jun 20, 2018
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Jun 20, 2018
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2021
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2021
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Dec 6, 2012
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Class II	Orthopedic	Contract manufacturing	Nov 14, 2018
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2021
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Nov 2, 2018
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Apr 29, 2020
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Jan 28, 2013
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	May 8, 2023
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Nov 2, 2018
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jun 15, 2021
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2021
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	May 13, 2020