AXIAL MEDICAL

Contract manufacturer · Ivyland, PA

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

2014Product codes first listed, by year (tallest: 8)2026

FDA registration: 3010863450 (openFDA record; or search FDA's registration database)
FEI number: 3010863450
Registered for: FDA registration year 2027
Establishment types: Contract manufacturer
Owner or operator: Axial Medical (FDA owner/operator no. 10046914)
Registered address: 65 Richard Rd, Ivyland, PA 18974
Contract listings: 92 device listings, 30 product codes, first listed May 29, 2014
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
DSI	Detector And Alarm, Arrhythmia	Class II	Cardiovascular	Contract manufacturing	Jan 12, 2022
FIP	Subsystem, Water Purification	Class II	Gastroenterology and urology	Contract manufacturing	Jan 12, 2022
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jan 15, 2025
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 3, 2018
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Dec 3, 2018
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract manufacturing	Nov 30, 2018
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Mar 31, 2015
JDS	Nail, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 3, 2018
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract manufacturing	Jan 6, 2022
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	May 29, 2014
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	May 29, 2014
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Mar 31, 2015
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	May 11, 2021
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	May 29, 2014
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	May 29, 2014
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Jan 12, 2022
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Class II	Cardiovascular	Contract manufacturing	Jan 12, 2022
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	May 29, 2014
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
NQP	Posterior Metal/Polymer Spinal System, Fusion	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Nov 21, 2016
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Mar 31, 2015
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Mar 31, 2015
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Nov 21, 2016
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Mar 31, 2015
PEK	Spinous Process Plate	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Jan 12, 2022