MedtechSourcebook

Acero Precision

Contract manufacturer · West Chester, PA

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

FDA registration
3000170817 (openFDA record; or search FDA's registration database)
FEI number
3000170817
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
ACERO PRECISION (FDA owner/operator no. 9072046)
Registered address
1340 Enterprise Drive, Suite 100, West Chester, PA 19380
Contract listings
90 device listings, 16 product codes, first listed Dec 10, 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 codeDevice (FDA name)ClassCategoryRoleFirst listed
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingJan 26, 2017
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingJan 26, 2017
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingDec 26, 2012
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingDec 10, 2012
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingDec 26, 2012
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingDec 26, 2012
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingDec 26, 2012
MQPSpinal Vertebral Body Replacement DeviceClass IIOrthopedicContract manufacturingDec 26, 2012
MRWSystem, Facet Screw Spinal DeviceUnclassifiedOrthopedicContract manufacturingDec 26, 2012
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingDec 26, 2012
NKGPosterior Cervical Screw SystemClass IIOrthopedicContract manufacturingDec 30, 2015
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingDec 26, 2012
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingJan 26, 2017
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingFeb 13, 2020
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingDec 26, 2012
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingJul 13, 2015