Avalign Technologies

FDA Filings

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

Avalign Technologies holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1421101
FEI Number1421101
NameAvalign German Specialty Instruments Division
Owner & OperatorAvalign Technologies
Contact Address8727 Clinton Park Drive
Fort Wayne IN 46825 US
Official Correspondent
  • Heidi Funston
  • x-260-4841500-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address626 Cooper Ct
SCHAUMBURG, IL 60173 US
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number1527105
FEI Number1000069183
NameINTEGRATED MEDICAL SOLUTIONS, INC
Owner & OperatorAvalign Technologies
Contact Address8727 Clinton Park Drive
Fort Wayne IN 46825 US
Official Correspondent
  • Heidi Funston
  • x-260-4841500-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7124 Industrial Park Blvd
MENTOR, OH 44060 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3008864603
FEI Number3008864603
NameAVALIGN TECHNOLOGIES
Owner & OperatorAvalign Technologies
Contact Address8727 Clinton Park Drive
Fort Wayne IN 46825 US
Official Correspondent
  • Heidi Funston
  • x-260-4841500-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8727 Clinton Park Dr
Fort Wayne, IN 46825 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number8010372
FEI Number3007290840
NameHeidi Funston
Owner & OperatorAvalign Technologies
Contact Address8727 Clinton Park Drive
Fort Wayne IN 46825 US
Official Correspondent
  • Heidi Funston
  • x-260-4841500-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8727 Clinton Park Drive
Fort Wayne, IN 46825 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
COMPR FT SCRW,4.0 STD,16-50MM LGTH2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
COMPR FT SCRW,4.0 STD,16-50MM LGTH2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
COMPR FT SCRW,4.0 STD,16-50MM LGTH2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
LO-PRO SCRW TM,SS 3.5X 12-18MMCORT2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
LO-PRO SCRW TM,SS 3.5X 12-18MMCORT2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Screw, Fixation Bone/Fastener Fixation2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Screw, Fixation Bone/Fastener Fixation2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Screw, Fixation Bone/Fastener Fixation2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Monolaxial Screw, Ti, 3.5X3.5X30mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Monolaxial Screw, Ti, 3.5X3.5X30mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
GUIDED GROWTH SYSTEM2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Washer, Bolt Nut2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Washer, Bolt Nut2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Minipolyaxial Screw Favored Angle (C/C), 3.5 X 3.0 X10mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Minipolyaxial Screw Favored Angle (C/C), 3.5 X 3.0 X10mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Minipolyaxial Screw Favored Angle (C/C), 3.5 X 3.0 X10mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Dual diameter Rod2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Dual diameter Rod2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
GROWTH GUIDANCE PLATE2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Mini Polyaxial Screw 3.0 X 3.5 X 8mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Mini Polyaxial Screw 3.0 X 3.5 X 8mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
3.5mm Minipoly Screw (4 thread head), 8mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
3.5mm Minipoly Screw (4 thread head), 8mm2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
One Hole Staple2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Mini Polyaxial Bone Screw2019-06-22
INTEGRATED MEDICAL SOLUTIONS, INC [Avalign Technologies]
Mini Polyaxial Bone Screw2019-06-22

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