Axi+Line Bunion Correction System

GUDID 00817701028109

Axi+Line Plate 5.0 Degree Left

NEXTREMITY SOLUTIONS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID00817701028109
NIH Device Record Key51b94ceb-c3a4-4159-bcb3-e054649ee934
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxi+Line Bunion Correction System
Version Model NumberAXJ-050L
Company DUNS060783407
Company NameNEXTREMITY SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817701028109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

On-Brand Devices [Axi+Line Bunion Correction System]

008177010208063.5 mm Locking Screw - 30 mm Length
008177010207903.5mm Locking Screw - 28mm
008177010207833.5 mm Locking Screw - 26 mm Length
008177010207763.5mm Locking Screw - 24mm
008177010207693.5mm Locking Screw - 22mm
008177010207523.5mm Locking Screw - 20mm
008177010207453.5mm Locking Screw - 18mm
008177010207383.5mm Locking Screw - 16mm
008177010207213.5mm Locking Screw - 14mm
008177010207143.5mm Locking Screw - 12mm
008177010207073.5mm Locking Screw - 10mm
008177010206913.5mm Cortical Screw - 30mm
008177010206843.5mm Cortical Screw - 28mm
008177010206773.5mm Cortical Screw - 26mm
008177010206603.5mm Cortical Screw - 24mm
008177010206533.5mm Cortical Screw - 22mm
008177010206463.5mm Cortical Screw - 20mm
008177010206393.5mm Cortical Screw - 18mm
008177010206223.5mm Cortical Screw - 16mm
008177010206153.5mm Cortical Screw - 14mm
008177010206083.5mm Cortical Screw - 12mm
008177010205923.5mm Cortical Screw - 10mm
00817701020585Axi+Line Plate 12.5 Degree - Right
00817701020578Axi+Line Plate 10.0 Degree - Right
00817701020561Axi+Line Plate 7.5 Degree - Right
00817701020554Axi+Line Plate 5.0 Degree - Right
00817701020547Axi+Line Plate 12.5 Degree - Left
00817701020530Axi+Line Plate 10.0 Degree - Left
00817701020523Axi+Line Plate 7.5 Degree - Left
00817701020516Axi+Line Plate 5.0 Degree - Left
00817701020509Axi+Line Instrument Kit - Right
00817701020493Axi+Line Instrument Kit - Left
00817701028178Axi+Line Plate 12.5 Degree Right
00817701028161Axi+Line Plate 12.5 Degree Left
00817701028154Axi+Line Plate 10.0 Degree Right
00817701028147Axi-Line Plate 10.0 Degree Left
00817701028130Axi+Line Plate 7.5 Degree Right
00817701028123Axi+Line Plate 7.5 Degree Left
00817701028116Axi+Line Plate 5.0 Degree Right
00817701028109Axi+Line Plate 5.0 Degree Left

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