Avalign Delivery Systems Division

FDA Filings

This page includes the latest FDA filings for Avalign Delivery Systems Division. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1835444
FEI Number3000717687
NameAvalign Delivery Systems Division
Owner & OperatorAvalign Delivery Systems Division
Contact Address2121 Southtech Drive Suite 600
Greenwood IN 46143 US
Official Correspondent
  • Thomas Clyne
  • x-317-8592300-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2121 SOUTHTECH DRIVE SUITE 600
Greenwood, IN 46143 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Avalign Delivery Systems Division
ALPS Proximal Humerus Plating System2020-04-02
Avalign Delivery Systems Division
Malibu2015-05-15
Avalign Delivery Systems Division
430-777 Release Laminoplasty Fixation2013-12-20
Avalign Delivery Systems Division
430-776 Release Laminoplasty Fixation2013-12-20
Avalign Delivery Systems Division
430-775 Release Laminoplasty Fixation2013-12-20
Avalign Delivery Systems Division
430-774 Release Laminoplasty Fixation2013-12-20
Avalign Delivery Systems Division
430-773 Release Laminoplasty Fixation2013-12-20
Avalign Delivery Systems Division
430-771 Release Laminoplasty Fixation2013-12-20
Avalign Delivery Systems Division
T2 XVBR 1.5 SPINAL SYSTEM2013-01-28
Avalign Delivery Systems Division
PowerPro System Sterilization Case, Small2013-01-28
Avalign Delivery Systems Division
Hall Sterilization Tray2013-01-28
Avalign Delivery Systems Division
Hall Sterilization Tray (for Lithium Battery Configuration)2013-01-28
Avalign Delivery Systems Division
Instrument, Manual Surgical for General2013-01-28
Avalign Delivery Systems Division
D1778092013-01-28
Avalign Delivery Systems Division
Steripack2007-12-05
Avalign Delivery Systems Division
D2025991996-07-19
Avalign Delivery Systems Division
B0673941996-07-19
Avalign Delivery Systems Division
9290-09 PEDESTAL SYSTEM NON-STERILE TR Pedestal1996-07-19
Avalign Delivery Systems Division
792-3 NEX-LINK CLOSURE TOP CADDIE LI NEX-LINK1996-07-19
Avalign Delivery Systems Division
792-18 HOOKS & OFFSET CONNECTOR CADDI NEX-LINK1996-07-19
Avalign Delivery Systems Division
792-17 NL CRSLNK, HOOKS & OFFST CN CA NEX-LINK1996-07-19
Avalign Delivery Systems Division
791-31-2 SELF-TAPPING THORACIC SCREW CA NEX-LINK1996-07-19
Avalign Delivery Systems Division
791-31 NEX-LINK THORACIC CADDIE NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-31 NEX-LINK THORACIC INSERT TRAY NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-30 NEX-LINK IMPLANT INSERT NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-29-2 SELF-TAPPING POLY SCREWS CADDI NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-29 SHORT SCREW CADDIE NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-28 SMOOTH SHANK CADDIE NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-27-2 LONG SELF-TAPPING POLY SCREW C NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-27 LONG SCREW CADDIE NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-26 CROSSLINK, HOOK & OFFSET CONN NEX-LINK1996-07-19
Avalign Delivery Systems Division
790-24 CLOSURE TOP CADDIE NEX-LINK1996-07-19
Avalign Delivery Systems Division
7091-06 CLOSURE TOP CADDIE Nex-Link OCT1996-07-19
Avalign Delivery Systems Division
7091-04 OPEN OFFSET CONNECTOR CADDIE Nex-Link OCT1996-07-19
Avalign Delivery Systems Division
7091-03 OCCIPITAL PLATE CADDIE Nex-Link OCT1996-07-19
Avalign Delivery Systems Division
7090-04 THERMOFORMED SMALL TRAY Nex-Link OCT1996-07-19
Avalign Delivery Systems Division
7090-03 THERMOFORMED IMPLANT TRAY Nex-Link OCT1996-07-19
Avalign Delivery Systems Division
7090-02 BASE LID Nex-Link OCT1996-07-19
Avalign Delivery Systems Division
7090-01 BRACKETED BASE Nex-Link OCT1996-07-19
Avalign Delivery Systems Division
430-771 Release Laminoplasty Fixation System1996-07-19
Avalign Delivery Systems Division
3590-75 7.5 PEDICLE SCREW CADDY PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-65 6.5 PEDICLE SCREW CADDY PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-55 5.5 PEDICLE SCREW CADDY PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-45 4.5 PEDICLE SCREW CADDY PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-24 TAP TRAY ACCSRY BIN MAT PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-23 CLASSIC TRAY AUXILIARY BIN MAT PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-22 CLASSIC TRAY INSERT PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-16 CLASSIC TRAY PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-15 MNPULTION TRAYII ACSRY BIN MAT PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-14 PATHFINDER II ACCSRY BIN MAT PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-13 MANIPULATION TRAY II PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-12 MANIPULATION TRAY I PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-11 STANDARD TRAY II PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-10 TAP TRAY INSERT PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-09 STANDARD TRAY I PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-08 PREBENT ROD TRAY PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-07 ROD BASE PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-06 IMPLANT BASE PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3590-05 CLOSURE TOP CADDY PathFinder NXT1996-07-19
Avalign Delivery Systems Division
3391-14 SEQUOIA ADD TRNSV CONN CADDY L SEQUOIA1996-07-19
Avalign Delivery Systems Division
3391-13 SEQUOIA ADD TRNSV CONN CADDY SEQUOIA1996-07-19
Avalign Delivery Systems Division
3391-12 SEQUOIA ACCESSORY BIN FINGER M SEQUOIA1996-07-19
Avalign Delivery Systems Division
3391-11 SEQUOIA CROSSLINK CADDY LID SEQUOIA1996-07-19
Avalign Delivery Systems Division
3391-10 SEQUOIA CLOSURE TOP CADDY LID SEQUOIA1996-07-19
Avalign Delivery Systems Division
3391-09 SEQUOIA CLOSURE TOP/CROSSLINK SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-17 SEQUOIA DEGEN ROD TRAY SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-16 SEQUOIA DEGEN 8.5MM SCREW SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-15 SEQUOIA DEGEN 7.5MM SCREW SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-14 SEQUOIA DEGEN 6.5MM SCREW SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-13 SEQUOIA DEGEN 5.5MM SCREW SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-12 SEQUOIA DEGEN 4.5MM SCREW SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-11 SEQUOIA DEGEN IMPLNT BASE SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-10 SEQUOIA TAP TRAY SS SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-08 SEQ DEGEN INSTR INS SS-1 SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-07 SEQ DEGEN INSTR BASE 2-SS SEQUOIA1996-07-19
Avalign Delivery Systems Division
3390-06 SEQUOIA DEGEN INSTRU BASE SEQUOIA1996-07-19
Avalign Delivery Systems Division
3290-34 34 TRIAL INSERT TRAY ARDIS1996-07-19
Avalign Delivery Systems Division
3290-30 30 TRIAL INSERT TRAY ARDIS1996-07-19
Avalign Delivery Systems Division
3290-26 26 TRIAL INSERT TRAY ARDIS1996-07-19
Avalign Delivery Systems Division
3290-22 22 TRIAL INSERT TRAY ARDIS1996-07-19
Avalign Delivery Systems Division
3290-07 SHAVER INSERT TRAY ARDIS1996-07-19
Avalign Delivery Systems Division
3290-06 ARDIS GENERAL OUTER BASE ARDIS1996-07-19
Avalign Delivery Systems Division
3290-05 ARDIS TRIALS OUTER BASE ARDIS1996-07-19
Avalign Delivery Systems Division
3017-02 UPPER TRAY, ACC CASE, T2 TiTLE 21996-07-19
Avalign Delivery Systems Division
2995-04 HARMONY ANT PREP & DISTRACT- S Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2995-03 HARMONY ANT PREP & DISTRACT- L Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2995-02 HARMONY ANT DISCECTOMY TRAY- S Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2995-01 HARMONY ANT DISCECTOMY TRAY- L Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2994-08 NEW DISTRCTOR MODULE NO. 2 Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2994-07 NEW DISTRACTION TRAY NO. 4 Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2994-06 HARMONY ANTERIOR DISTRACTOR MO Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2994-03 HARMONY ANTERIOR PREPARATION T Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2994-02 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2994-01 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior1996-07-19
Avalign Delivery Systems Division
2790-04 HARMONY SMTH & CTTNG DISTR INS Harmony Posterior1996-07-19
Avalign Delivery Systems Division
2790-03 HARMONY INSTRUMENT INSERT Harmony Posterior1996-07-19
Avalign Delivery Systems Division
2790-02 HARMONY STANDARD INSTRUMENTS I Harmony Posterior1996-07-19
Avalign Delivery Systems Division
2790-01 HARMONY STANDARD INSTRUMENTS I Harmony Posterior1996-07-19
Avalign Delivery Systems Division
2695-06 TRAXIS FXD INSTR OUTER CASE TA TRAXIS1996-07-19
Avalign Delivery Systems Division
2695-05 TRAXIS FXD INSTR OUTER CASE TA TRAXIS1996-07-19
Avalign Delivery Systems Division
2695-04 TRAXIS MOD INSTR OUTER CASE TA TRAXIS1996-07-19
Avalign Delivery Systems Division
2695-03 TRAXIS MOD INSTR OUTER CASE TA TRAXIS1996-07-19
Avalign Delivery Systems Division
2692-3 CADDY LID 2 TRAXIS1996-07-19
Avalign Delivery Systems Division
2692-2 CADDY LID 1 TRAXIS1996-07-19
Avalign Delivery Systems Division
2691-2 CADDY TRAXIS1996-07-19
Avalign Delivery Systems Division
2690-8 TRAXIS MODULAR INSERT TRAY TRAXIS1996-07-19
Avalign Delivery Systems Division
2690-7 TRAXIS FIXED TRAY INSERT TRAXIS1996-07-19
Avalign Delivery Systems Division
2143 LID T-LINK CADDY, TITLE 2 MINIT (TiTLE 2)1996-07-19
Avalign Delivery Systems Division
2142 T-LINK CADDY, TITLE 2 MINIT (TiTLE 2)1996-07-19
Avalign Delivery Systems Division
2140 SCREW CADDY IMP TITLE 2 MINIT (TiTLE 2)1996-07-19
Avalign Delivery Systems Division
1992-01 THERMOFORMED CADDY LID Harmony1996-07-19
Avalign Delivery Systems Division
1790-36 MULTILEVEL TOP INSERT CADDY HO ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-35 MULTI-LEVEL INSTRUMENT INSERT ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-33 MULTI LEVEL 4 LEVEL CADDY ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-31 MULTI LEVEL 3 LEVEL CADDY ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-29 MULTI LEVEL CADDY LID ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-28 MULTI LEVEL 2 LEVEL CADDY ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-27 SINGLE LEVEL INSTRUMENT INSERT ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-26 SINGLE LEVEL CADDY LID - RIGHT ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-25 SINGLE LEVEL CADDY ANT-CER1996-07-19
Avalign Delivery Systems Division
1790-24 SINGLE LEVEL CADDY LID - LEFT ANT-CER1996-07-19
Avalign Delivery Systems Division
1591-1 CADENCE TRIALS CADDY CADENCE1996-07-19
Avalign Delivery Systems Division
1590-8 CADENCE INSERT TRAY 2 CADENCE1996-07-19
Avalign Delivery Systems Division
1590-7 CADENCE INSERT TRAY 1 CADENCE1996-07-19
Avalign Delivery Systems Division
1095-101 METAL GENERIC BASE LID Generic1996-07-19
Avalign Delivery Systems Division
1095-021 2" METAL GENERIC OUTER BASE Generic1996-07-19
Avalign Delivery Systems Division
02557 MINIT IMPL CASE,CADY 2LID MINIT (TiTLE 2)1996-07-19
Avalign Delivery Systems Division
02555 MINIT IMPL CASE, CADDY 1 MINIT (TiTLE 2)1996-07-19
Avalign Delivery Systems Division
02551 BASE, IMPLANT CASE, MINIT MINIT (TiTLE 2)1996-07-19

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