Mendell

Contract manufacturer · Lakeville, MN

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

2012Product codes first listed, by year (tallest: 17)2026

FDA registration: 3009998573 (openFDA record; or search FDA's registration database)
FEI number: 3009998573
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: Mendell Machine and Manufacturing, LLC (FDA owner/operator no. 10042591)
Registered address: 21463 Grenada Ave, Lakeville, MN 55044
Contract listings: 75 device listings, 39 product codes, first listed Dec 11, 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	Mar 21, 2013
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2014
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Mar 22, 2013
GCZ	Retainer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Mar 22, 2013
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Mar 22, 2013
GFC	Driver, Surgical, Pin	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2014
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 23, 2013
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	May 17, 2013
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Feb 25, 2015
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Jan 30, 2014
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 23, 2013
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Mar 22, 2013
HWT	Template	Class I	Orthopedic	Contract manufacturing	Mar 21, 2013
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Mar 22, 2013
HXP	Instrument, Bending Or Contouring	Class I	Orthopedic	Contract manufacturing	Jan 30, 2014
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Mar 21, 2013
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Jan 30, 2013
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Nov 12, 2014
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Dec 11, 2012
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Dec 18, 2012
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 30, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Mar 21, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 30, 2013
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 18, 2012
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract manufacturing	Jan 30, 2013
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Dec 11, 2012
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Dec 11, 2012
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Dec 18, 2012
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Dec 18, 2012
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Class II	Neurology	Contract manufacturing	Aug 18, 2026
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Dec 11, 2012
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Aug 18, 2026
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Dec 18, 2012
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Apr 1, 2022
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 18, 2012
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
PFH	Venous Window Needle Guide	Class II	Gastroenterology and urology	Contract manufacturing	Sep 9, 2015
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Aug 18, 2026
QGA	Penile Implant Surgical Accessories	Class I	Gastroenterology and urology	Contract manufacturing	Apr 10, 2020