ARCH - Quakertown

Contract manufacturer · Quakertown, PA

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

2012Product codes first listed, by year (tallest: 20)2026

FDA registration: 2531477 (openFDA record; or search FDA's registration database)
FEI number: 3001642380
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: ARCH - Quakertown (FDA owner/operator no. 9033309)
Registered address: 140 PENN AM DR., Quakertown, PA 18951
Contract listings: 60 device listings, 35 product codes, first listed Dec 5, 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	Aug 6, 2025
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jun 28, 2024
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
GFI	Osteotome, Manual	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
HTD	Forceps	Class I	General and plastic surgery	Contract manufacturing	Mar 27, 2018
HTQ	Broach	Class I	Orthopedic	Contract manufacturing	Jul 11, 2024
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Jan 31, 2013
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HWT	Template	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Dec 19, 2023
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class III	Orthopedic	Contract manufacturing	Jan 31, 2013
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 11, 2014
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Dec 5, 2012
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Class II	Orthopedic	Contract manufacturing	Feb 19, 2016
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Jan 31, 2013
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 11, 2014
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Dec 5, 2012
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 11, 2014
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jul 28, 2025
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 13, 2016
PGM	Growing Rod System	Class II	Orthopedic	Contract manufacturing	Dec 19, 2023
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Jun 9, 2026