CoLink® 2

GUDID 00810021862682

CoLink® 2 H-Plate, Large

IN2BONES USA, LLC

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 ID00810021862682
NIH Device Record Keyd20d8a25-a2e4-448e-865c-1fd410ab1081
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoLink® 2
Version Model NumberP42 ST023
Company DUNS079700711
Company NameIN2BONES USA, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]
GS100810021862682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
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 Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [CoLink® 2]

00810021863696CoLink® VAL Screw, Ø3.0 X 60mm
00810021863689CoLink® VAL Screw, Ø3.0 X 57.5mm
00810021863672CoLink® VAL Screw, Ø3.0 X 55mm
00810021863665CoLink® VAL Screw, Ø3.0 X 52.5mm
00810021863658CoLink® VAL Screw, Ø3.0 X 50mm
00810021863641CoLink® VAL Screw, Ø3.0 X 47.5mm
00810021863634CoLink® VAL Screw, Ø3.0 X 45mm
00810021863627CoLink® VAL Screw, Ø3.0 X 42.5mm
00810021863610CoLink® VAL Screw, Ø3.0 X 40mm
00810021863603CoLink® VAL Screw, Ø3.0 X 38mm
00810021863597CoLink® VAL Screw, Ø3.0 X 36mm
00810021863580CoLink® VAL Screw, Ø3.0 X 34mm
00810021863573CoLink® VAL Screw, Ø3.0 X 32mm
00810021863566CoLink® VAL Screw, Ø3.0 X 30mm
00810021863559CoLink® VAL Screw, Ø3.0 X 28mm
00810021863542CoLink® VAL Screw, Ø3.0 X 26mm
00810021863535CoLink® VAL Screw, Ø3.0 X 24mm
00810021863528CoLink® VAL Screw, Ø3.0 X 22mm
00810021863511CoLink® VAL Screw, Ø3.0 X 20mm
00810021863504CoLink® VAL Screw, Ø3.0 X 18mm
00810021863498CoLink® VAL Screw, Ø3.0 X 16mm
00810021863481CoLink® VAL Screw, Ø3.0 X 14mm
00810021863474CoLink® VAL Screw, Ø3.0 X 12mm
00810021863467CoLink® VAL Screw, Ø3.0 X 10mm
00810021863450CoLink® VAL Screw, Ø3.0 X 8mm
00810021863443CoLink® Locking Screw, Ø3.0 X 60mm
00810021863436CoLink® Locking Screw, Ø3.0 X 57.5mm
00810021863429CoLink® Locking Screw, Ø3.0 X 55mm
00810021863412CoLink® Locking Screw, Ø3.0 X 52.5mm
00810021863405CoLink® Locking Screw, Ø3.0 X 50mm
00810021863399CoLink® Locking Screw, Ø3.0 X 47.5mm
00810021863382CoLink® Locking Screw, Ø3.0 X 45mm
00810021863375CoLink® Locking Screw, Ø3.0 X 42.5mm
00810021863368CoLink® Locking Screw, Ø3.0 X 40mm
00810021863351CoLink® Locking Screw, Ø3.0 X 38mm
00810021863344CoLink® Locking Screw, Ø3.0 X 36mm
00810021863337CoLink® Locking Screw, Ø3.0 X 34mm
00810021863320CoLink® Locking Screw, Ø3.0 X 32mm
00810021863313CoLink® Locking Screw, Ø3.0 X 30mm
00810021863306CoLink® Locking Screw, Ø3.0 X 28mm
00810021863290CoLink® Locking Screw, Ø3.0 X 26mm
00810021863283CoLink® Locking Screw, Ø3.0 X 24mm
00810021863276CoLink® Locking Screw, Ø3.0 X 22mm
00810021863269CoLink® Locking Screw, Ø3.0 X 20mm
00810021863252CoLink® Locking Screw, Ø3.0 X 18mm
00810021863245CoLink® Locking Screw, Ø3.0 X 16mm
00810021863238CoLink® Locking Screw, Ø3.0 X 14mm
00810021863221CoLink® Locking Screw, Ø3.0 X 12mm
00810021863214CoLink® Locking Screw, Ø3.0 X 10mm
00810021863207CoLink® Locking Screw, Ø3.0 X 8mm

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