FDA Registration
Active
🇺🇸 United States
1790-36 MULTILEVEL TOP INSERT CADDY HO ANT-CER
Reg #: 1835444
·
FEI: 3000717687
·
Expires 2025
Products
1
Proprietary Names
114
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Avalign Delivery Systems Division
- Registration Number
- 1835444
- FEI Number
- 3000717687
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2121 SOUTHTECH DRIVE, SUITE 600
- City
- Greenwood
- State
- IN
- ZIP
- 46143
- Country
- US
Owner / Operator
- Firm Name
- Avalign Delivery Systems Division
- Operator Number
- 9026184
- Address
- 2121 Southtech Drive, Suite 600
- City
- Greenwood
- State
- IN
- Postal Code
- 46143
- Country
- US
- Correspondent
- Thomas Clyne
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1996-07-19 |
Proprietary Names
1790-36 MULTILEVEL TOP INSERT CADDY HO ANT-CER
3391-11 SEQUOIA CROSSLINK CADDY LID SEQUOIA
3590-16 CLASSIC TRAY PathFinder NXT
2690-8 TRAXIS MODULAR INSERT TRAY TRAXIS
3590-13 MANIPULATION TRAY II PathFinder NXT
2790-01 HARMONY STANDARD INSTRUMENTS I Harmony Posterior
3290-06 ARDIS GENERAL OUTER BASE ARDIS
2994-02 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior
2994-07 NEW DISTRACTION TRAY NO. 4 Harmony Anterior
3390-10 SEQUOIA TAP TRAY SS SEQUOIA
02555 MINIT IMPL CASE, CADDY 1 MINIT (TiTLE 2)
3590-65 6.5 PEDICLE SCREW CADDY PathFinder NXT
3290-30 30 TRIAL INSERT TRAY ARDIS
3590-10 TAP TRAY INSERT PathFinder NXT
3390-06 SEQUOIA DEGEN INSTRU BASE SEQUOIA
2695-05 TRAXIS FXD INSTR OUTER CASE TA TRAXIS
7090-01 BRACKETED BASE Nex-Link OCT
3590-15 MNPULTION TRAYII ACSRY BIN MAT PathFinder NXT
3390-16 SEQUOIA DEGEN 8.5MM SCREW SEQUOIA
1095-101 METAL GENERIC BASE LID Generic
2995-03 HARMONY ANT PREP & DISTRACT- L Harmony Anterior
2790-02 HARMONY STANDARD INSTRUMENTS I Harmony Posterior
3290-22 22 TRIAL INSERT TRAY ARDIS
3390-15 SEQUOIA DEGEN 7.5MM SCREW SEQUOIA
02557 MINIT IMPL CASE,CADY 2LID MINIT (TiTLE 2)
3391-12 SEQUOIA ACCESSORY BIN FINGER M SEQUOIA
2790-03 HARMONY INSTRUMENT INSERT Harmony Posterior
2994-06 HARMONY ANTERIOR DISTRACTOR MO Harmony Anterior
1790-27 SINGLE LEVEL INSTRUMENT INSERT ANT-CER
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
791-31 NEX-LINK THORACIC CADDIE NEX-LINK
790-28 SMOOTH SHANK CADDIE NEX-LINK
3390-14 SEQUOIA DEGEN 6.5MM SCREW SEQUOIA
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
3391-09 SEQUOIA CLOSURE TOP/CROSSLINK SEQUOIA
7090-02 BASE LID Nex-Link OCT
7091-04 OPEN OFFSET CONNECTOR CADDIE Nex-Link OCT
3017-02 UPPER TRAY, ACC CASE, T2 TiTLE 2
1590-7 CADENCE INSERT TRAY 1 CADENCE
9290-09 PEDESTAL SYSTEM NON-STERILE TR Pedestal
1790-29 MULTI LEVEL CADDY LID ANT-CER
1790-28 MULTI LEVEL 2 LEVEL CADDY ANT-CER
3391-13 SEQUOIA ADD TRNSV CONN CADDY SEQUOIA
3390-13 SEQUOIA DEGEN 5.5MM SCREW SEQUOIA
1095-021 2" METAL GENERIC OUTER BASE Generic
3391-14 SEQUOIA ADD TRNSV CONN CADDY L SEQUOIA
3590-22 CLASSIC TRAY INSERT PathFinder NXT
3290-07 SHAVER INSERT TRAY ARDIS
3390-07 SEQ DEGEN INSTR BASE 2-SS SEQUOIA
3290-05 ARDIS TRIALS OUTER BASE ARDIS
1790-26 SINGLE LEVEL CADDY LID - RIGHT ANT-CER
430-771 Release Laminoplasty Fixation System
790-31 NEX-LINK THORACIC INSERT TRAY NEX-LINK
7090-04 THERMOFORMED SMALL TRAY Nex-Link OCT
B067394
2995-02 HARMONY ANT DISCECTOMY TRAY- S Harmony Anterior
1591-1 CADENCE TRIALS CADDY CADENCE
2692-2 CADDY LID 1 TRAXIS
1590-8 CADENCE INSERT TRAY 2 CADENCE
2695-03 TRAXIS MOD INSTR OUTER CASE TA TRAXIS
790-27 LONG SCREW CADDIE NEX-LINK
792-18 HOOKS & OFFSET CONNECTOR CADDI NEX-LINK
790-26 CROSSLINK, HOOK & OFFSET CONN NEX-LINK
3590-05 CLOSURE TOP CADDY PathFinder NXT
3590-06 IMPLANT BASE PathFinder NXT
790-29 SHORT SCREW CADDIE NEX-LINK
3390-17 SEQUOIA DEGEN ROD TRAY SEQUOIA
3590-11 STANDARD TRAY II PathFinder NXT
2143 LID T-LINK CADDY, TITLE 2 MINIT (TiTLE 2)
3590-45 4.5 PEDICLE SCREW CADDY PathFinder NXT
2695-06 TRAXIS FXD INSTR OUTER CASE TA TRAXIS
2691-2 CADDY TRAXIS
2692-3 CADDY LID 2 TRAXIS
3590-08 PREBENT ROD TRAY PathFinder NXT
2790-04 HARMONY SMTH & CTTNG DISTR INS Harmony Posterior
2995-01 HARMONY ANT DISCECTOMY TRAY- L Harmony Anterior
3390-12 SEQUOIA DEGEN 4.5MM SCREW SEQUOIA
1992-01 THERMOFORMED CADDY LID Harmony
7091-06 CLOSURE TOP CADDIE Nex-Link OCT
1790-24 SINGLE LEVEL CADDY LID - LEFT ANT-CER
3590-12 MANIPULATION TRAY I PathFinder NXT
1790-33 MULTI LEVEL 4 LEVEL CADDY ANT-CER
790-24 CLOSURE TOP CADDIE NEX-LINK
2695-04 TRAXIS MOD INSTR OUTER CASE TA TRAXIS
790-30 NEX-LINK IMPLANT INSERT NEX-LINK
791-31-2 SELF-TAPPING THORACIC SCREW CA NEX-LINK
2142 T-LINK CADDY, TITLE 2 MINIT (TiTLE 2)
2994-01 HARMONY ANTERIOR DISCECTOMY TR Harmony Anterior
3590-09 STANDARD TRAY I PathFinder NXT
3590-07 ROD BASE PathFinder NXT
3590-14 PATHFINDER II ACCSRY BIN MAT PathFinder NXT
1790-31 MULTI LEVEL 3 LEVEL CADDY ANT-CER
D202599
3391-10 SEQUOIA CLOSURE TOP CADDY LID SEQUOIA
7090-03 THERMOFORMED IMPLANT TRAY Nex-Link OCT
792-17 NL CRSLNK, HOOKS & OFFST CN CA NEX-LINK
7091-03 OCCIPITAL PLATE CADDIE Nex-Link OCT
2690-7 TRAXIS FIXED TRAY INSERT TRAXIS
2994-08 NEW DISTRCTOR MODULE NO. 2 Harmony Anterior
02551 BASE, IMPLANT CASE, MINIT MINIT (TiTLE 2)
2140 SCREW CADDY IMP TITLE 2 MINIT (TiTLE 2)
3590-23 CLASSIC TRAY AUXILIARY BIN MAT PathFinder NXT
3290-26 26 TRIAL INSERT TRAY ARDIS
3590-55 5.5 PEDICLE SCREW CADDY PathFinder NXT
3590-24 TAP TRAY ACCSRY BIN MAT PathFinder NXT
1790-35 MULTI-LEVEL INSTRUMENT INSERT ANT-CER
3590-75 7.5 PEDICLE SCREW CADDY PathFinder NXT
790-29-2 SELF-TAPPING POLY SCREWS CADDI NEX-LINK
3390-11 SEQUOIA DEGEN IMPLNT BASE SEQUOIA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)