Avalign Delivery Systems Division

Contract manufacturer · Greenwood, IN

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

1996Product codes first listed, by year (tallest: 12)2026

FDA registration: 1835444 (openFDA record; or search FDA's registration database)
FEI number: 3000717687
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: Avalign Delivery Systems Division (FDA owner/operator no. 9026184)
Registered address: 2121 SOUTHTECH DRIVE, SUITE 600, Greenwood, IN 46143
Contract listings: 49 device listings, 43 product codes, first listed Jul 19, 1996
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
ETN	Stimulator, Nerve	Class II	Ear, nose and throat	Contract manufacturing	Jan 29, 2026
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jul 19, 1996
GZT	Retractor, Self-Retaining, For Neurosurgery	Class II	Neurology	Contract manufacturing	Jun 15, 2016
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class II	Neurology	Contract manufacturing	Sep 18, 2023
HCF	Instrument, Ligature Passing And Knot Tying	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2013
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Apr 2, 2020
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Sep 13, 2023
HTD	Forceps	Class I	General and plastic surgery	Contract manufacturing	Sep 30, 2026
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Sep 13, 2023
HWT	Template	Class I	Orthopedic	Contract manufacturing	Dec 3, 2025
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 30, 2014
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General hospital	Contract manufacturing	Dec 5, 2007
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Mar 4, 2016
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Apr 16, 2026
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Apr 16, 2026
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 30, 2014
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract manufacturing	Dec 20, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Jan 28, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 30, 2014
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Class II	Orthopedic	Contract manufacturing	Jan 30, 2014
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Apr 16, 2026
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 30, 2014
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	May 16, 2016
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract manufacturing	Jan 30, 2014
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Jan 28, 2013
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract manufacturing	Jan 30, 2014
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	Sep 23, 2016
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Class III	Orthopedic	Contract manufacturing	Mar 4, 2016
OJH	Orthopedic Tray	Class I	General and plastic surgery	Contract manufacturing	May 15, 2015
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Dec 15, 2020
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Sep 18, 2023
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Class II	Orthopedic	Contract manufacturing	Apr 16, 2026
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	Apr 16, 2026
QLR	Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices	Class II	Orthopedic	Contract manufacturing	Dec 22, 2025