Avalign Delivery Systems Division

FDA Device Registration & Listing · Greenwood, IN, US · Registration 1835444

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1835444
FEI Number
3000717687
Entity Name
Avalign Delivery Systems Division
City/State/Country
Greenwood, IN, US
Establishment Address
2121 SOUTHTECH DRIVE, SUITE 600, Greenwood, IN 46143, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Avalign Delivery Systems Division (Owner Number: 9026184)
Owner / Operator Contact Address
2121 Southtech Drive, Suite 600, Greenwood, IN 46143, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ALPS Proximal Humerus Plating System Mako Shoulder Application Malibu Navigated Anterolateral Disc Prep Instruments CrossRoads Modular Tray System TriLEAP Plating System VOLT Proximal Humerus 3.5 Plating System DePuy Synthes MatrixSTERNUM Fixation System are registered as an accessory to Plate, fixation, bone under the Product Code in 510(k) submission K221809 Avalign Delivery Systems does not manufacture Plate, fixation, bone. This listing has been made because cases and trays Steripack Instrument, Manual Surgical for General Midas Rex Attachments and Dissecting Tools for Mazor TRILEAP Plating System VOLT Mini Fragment and VOLT Small Fragment D177809 Mako Instrument Trays 3590-08 PREBENT ROD TRAY PathFinder NXT 2790-04 HARMONY SMTH & CTTNG DISTR INS Harmony Posterior 1992-01 THERMOFORMED CADDY LID Harmony 2995-01 HARMONY ANT DISCECTOMY TRAY- L Harmony Anterior 1790-24 SINGLE LEVEL CADDY LID - LEFT ANT-CER 3590-12 MANIPULATION TRAY I PathFinder NXT 9290-09 PEDESTAL SYSTEM NON-STERILE TR Pedestal 790-29 SHORT SCREW CADDIE NEX-LINK 1790-33 MULTI LEVEL 4 LEVEL CADDY ANT-CER 791-31-2 SELF-TAPPING THORACIC SCREW CA NEX-LINK 3590-09 STANDARD TRAY I PathFinder NXT 3590-07 ROD BASE PathFinder NXT 3390-17 SEQUOIA DEGEN ROD TRAY SEQUOIA 2143 LID T-LINK CADDY, TITLE 2 MINIT (TiTLE 2) 3590-45 4.5 PEDICLE SCREW CADDY PathFinder NXT 3590-16 CLASSIC TRAY PathFinder NXT 2690-8 TRAXIS MODULAR INSERT TRAY TRAXIS 3590-13 MANIPULATION TRAY II PathFinder NXT 790-27 LONG SCREW CADDIE NEX-LINK 2994-01 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior 792-18 HOOKS & OFFSET CONNECTOR CADDI NEX-LINK 2994-03 HARMONY ANTERIOR PREPARATION T Harmony Anterior 1790-25 SINGLE LEVEL CADDY ANT-CER 3290-34 34 TRIAL INSERT TRAY ARDIS 792-3 NEX-LINK CLOSURE TOP CADDIE LI NEX-LINK 2995-03 HARMONY ANT PREP & DISTRACT- L Harmony Anterior 2790-02 HARMONY STANDARD INSTRUMENTS I Harmony Posterior 3290-05 ARDIS TRIALS OUTER BASE ARDIS 3290-22 22 TRIAL INSERT TRAY ARDIS 2690-7 TRAXIS FIXED TRAY INSERT TRAXIS 2692-2 CADDY LID 1 TRAXIS 7091-04 OPEN OFFSET CONNECTOR CADDIE Nex-Link OCT 2695-03 TRAXIS MOD INSTR OUTER CASE TA TRAXIS 2994-08 NEW DISTRCTOR MODULE NO. 2 Harmony Anterior 2140 SCREW CADDY IMP TITLE 2 MINIT (TiTLE 2) 3391-12 SEQUOIA ACCESSORY BIN FINGER M SEQUOIA 02555 MINIT IMPL CASE, CADDY 1 MINIT (TiTLE 2) 3391-09 SEQUOIA CLOSURE TOP/CROSSLINK SEQUOIA 2994-06 HARMONY ANTERIOR DISTRACTOR MO Harmony Anterior 3391-13 SEQUOIA ADD TRNSV CONN CADDY SEQUOIA 3390-13 SEQUOIA DEGEN 5.5MM SCREW SEQUOIA 3390-12 SEQUOIA DEGEN 4.5MM SCREW SEQUOIA 1790-28 MULTI LEVEL 2 LEVEL CADDY ANT-CER 7091-06 CLOSURE TOP CADDIE Nex-Link OCT 1591-1 CADENCE TRIALS CADDY CADENCE 7090-02 BASE LID Nex-Link OCT 3017-02 UPPER TRAY, ACC CASE, T2 TiTLE 2 3290-26 26 TRIAL INSERT TRAY ARDIS 2994-02 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior 3590-24 TAP TRAY ACCSRY BIN MAT PathFinder NXT 7090-03 THERMOFORMED IMPLANT TRAY Nex-Link OCT 7091-03 OCCIPITAL PLATE CADDIE Nex-Link OCT 3390-10 SEQUOIA TAP TRAY SS SEQUOIA 2790-03 HARMONY INSTRUMENT INSERT Harmony Posterior 792-17 NL CRSLNK, HOOKS & OFFST CN CA NEX-LINK 3590-65 6.5 PEDICLE SCREW CADDY PathFinder NXT 790-24 CLOSURE TOP CADDIE NEX-LINK 2695-04 TRAXIS MOD INSTR OUTER CASE TA TRAXIS 790-30 NEX-LINK IMPLANT INSERT NEX-LINK 3390-07 SEQ DEGEN INSTR BASE 2-SS SEQUOIA 1790-26 SINGLE LEVEL CADDY LID - RIGHT ANT-CER 3590-10 TAP TRAY INSERT PathFinder NXT 3590-14 PATHFINDER II ACCSRY BIN MAT PathFinder NXT 2695-05 TRAXIS FXD INSTR OUTER CASE TA TRAXIS 1790-31 MULTI LEVEL 3 LEVEL CADDY ANT-CER 7090-01 BRACKETED BASE Nex-Link OCT 3390-14 SEQUOIA DEGEN 6.5MM SCREW SEQUOIA 3391-10 SEQUOIA CLOSURE TOP CADDY LID SEQUOIA 3390-15 SEQUOIA DEGEN 7.5MM SCREW SEQUOIA 1590-8 CADENCE INSERT TRAY 2 CADENCE 02557 MINIT IMPL CASE,CADY 2LID MINIT (TiTLE 2) 3590-15 MNPULTION TRAYII ACSRY BIN MAT PathFinder NXT 1095-101 METAL GENERIC BASE LID Generic 430-771 Release Laminoplasty Fixation System 1095-021 2" METAL GENERIC OUTER BASE Generic 3590-75 7.5 PEDICLE SCREW CADDY PathFinder NXT 3590-22 CLASSIC TRAY INSERT PathFinder NXT 3290-07 SHAVER INSERT TRAY ARDIS 790-29-2 SELF-TAPPING POLY SCREWS CADDI NEX-LINK 3390-11 SEQUOIA DEGEN IMPLNT BASE SEQUOIA 3390-16 SEQUOIA DEGEN 8.5MM SCREW SEQUOIA 3590-23 CLASSIC TRAY AUXILIARY BIN MAT PathFinder NXT 1790-35 MULTI-LEVEL INSTRUMENT INSERT ANT-CER 3391-14 SEQUOIA ADD TRNSV CONN CADDY L SEQUOIA 3290-30 30 TRIAL INSERT TRAY ARDIS 1790-36 MULTILEVEL TOP INSERT CADDY HO ANT-CER 790-28 SMOOTH SHANK CADDIE NEX-LINK 3391-11 SEQUOIA CROSSLINK CADDY LID SEQUOIA 790-31 NEX-LINK THORACIC INSERT TRAY NEX-LINK 7090-04 THERMOFORMED SMALL TRAY Nex-Link OCT 791-31 NEX-LINK THORACIC CADDIE NEX-LINK D202599 B067394 2995-02 HARMONY ANT DISCECTOMY TRAY- S Harmony Anterior 1790-29 MULTI LEVEL CADDY LID ANT-CER 2695-06 TRAXIS FXD INSTR OUTER CASE TA TRAXIS 02551 BASE, IMPLANT CASE, MINIT MINIT (TiTLE 2) 2691-2 CADDY TRAXIS 2790-01 HARMONY STANDARD INSTRUMENTS I Harmony Posterior 3290-06 ARDIS GENERAL OUTER BASE ARDIS 3590-55 5.5 PEDICLE SCREW CADDY PathFinder NXT 2994-07 NEW DISTRACTION TRAY NO. 4 Harmony Anterior 790-26 CROSSLINK, HOOK & OFFSET CONN NEX-LINK 3590-06 IMPLANT BASE PathFinder NXT 1590-7 CADENCE INSERT TRAY 1 CADENCE 3590-11 STANDARD TRAY II PathFinder NXT 790-27-2 LONG SELF-TAPPING POLY SCREW C NEX-LINK 2995-04 HARMONY ANT PREP & DISTRACT- S Harmony Anterior 3390-08 SEQ DEGEN INSTR INS SS-1 SEQUOIA 2142 T-LINK CADDY, TITLE 2 MINIT (TiTLE 2) 2692-3 CADDY LID 2 TRAXIS 3590-05 CLOSURE TOP CADDY PathFinder NXT 1790-27 SINGLE LEVEL INSTRUMENT INSERT ANT-CER 3390-06 SEQUOIA DEGEN INSTRU BASE SEQUOIA 6553002 Hall Sterilization Tray (for Lithium Battery Configuration) Hall Sterilization Tray PowerPro System Sterilization Case, Small and lumbar in K212524 Avalign Delivery Systems does not manufacture intervertebral fusion device with bone graft, lumbar. This listing is because Medtronic cases / trays are registered as accessories to the intervertebral fusion device with bone graft, Medtronic Reusable Instruments and Accessories Avalign Delivery Systems does not manufacture appliance, fixation, spinal intervertebral body.This listing has been made because Medtronic cases and trays are registered as an accessory to the listed devices in K141632. Avalign Delivery Systems does not manufacture posterior cervical screw system. This listing has been made because Medtronic cases and trays are registered as accessories to the posterior cervical screw system in K163375 Synthes Graphic Case & Tray System Avalign Delivery Systems does not manufacture ROD, FIXATION, INTRAMEDULLARY. This listing has been made because cases and trays are registered as an accessory to ROD, FIXATION, INTRAMEDULLARY under product code in 510k submission K201346 because Medtronic cases and trays are registered as accessories to tthoracolumbosacral pedicle screw system in K153589 Avalign Delivery Systems does not manufacture thoracolumbosacral pedicle screw system. This listing has been made

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-04-02
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2016-09-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-05-17
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2015-05-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-08-21
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-08-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-01-26
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-09-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-10-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-06-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-06-03
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2026-01-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-09-13
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2016-06-15
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-03-04
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2007-12-05
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-01-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-12-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-11-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-11-25
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2014-01-30
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2014-01-30
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-01-30
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2014-01-30
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-01-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-07-17
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-28
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-09-23
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-07-19
NTG Prosthesis, Ankle, Uncemented, Non-Constrained Unknown Class 3 N/A 2016-03-04
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2013-01-30
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-09-18
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-01-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-09-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-09-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-09-18
HWT Template Orthopedic Class 1 888.4800 2025-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-09-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-03-04
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2023-09-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-09-18
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-06-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-09-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-09-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-09-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-09-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-09-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-09-18
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2023-09-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-09-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-04-16
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2026-04-16
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-04-16
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2026-04-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2026-04-16

Official Correspondent

Thomas Clyne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avalign Delivery Systems Division
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0040-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3017609305 PRIMEMED INC. Sungnam-city Gyeonggi, KR
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835444. Last updated year: 2026. Please use registration number 1835444 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.