In2Bones USA

GUDID 00810021862040

CoLink CFX MIS Plate, Ext, Large, Right

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 Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID00810021862040
NIH Device Record Key9d1c4745-9a0f-4dcc-8242-ce60d77adf1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIn2Bones USA
Version Model NumberP80 ST122
Company DUNS079700711
Company NameIN2BONES USA, LLC
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 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
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [Primary]
GS100810021862040 [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
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 [In2Bones USA]

00817906029994Lag Screw Countersink, 2.0/2.5
00817906029987Lag Screw Drill, Cannulated 1.6
00817906029970Lag Screw Driver, T7 Cannulated
00817906029963LAG SCREW COUNTERSINK, HUDSON, Ø5.0
00817906029956LAG SCREW DRILL, CANNULATED, HUDSON, Ø4.8
00817906029949LAG SCREW DRILL, CANNULATED, HUDSON, Ø3.3
00817906029932K-WIRE, S. TROCAR, SMOOTH, .031X4"
00817906029925LAG SCREW COUNTERSINK, Ø6.7
00817906029918LAG SCREW COUNTERSINK, Ø4.0/Ø5.0
00817906029901LAG SCREW COUNTERSINK, Ø3.0
00817906029895LAG SCREW DRILL, CANNULATED, Ø4.8
00817906029888LAG SCREW DRILL, CANNULATED, Ø3.3
00817906029871LAG SCREW DRILL, CANNULATED, Ø2.7
00817906029864LAG SCREW DRILL, CANNULATED, Ø2.1
00817906029857LAG SCREW DRIVER, T15, CANNULATED
00817906029840LAG SCREW DRIVER, T8, CANNULATED
00817906029833K-WIRE, S. TROCAR, SMOOTH, .087X7"
00817906029826K-WIRE, S. TROCAR, SMOOTH, .062X6"
00817906029819K-WIRE, S. TROCAR, SMOOTH, .062X7"
00817906029802K-WIRE, S. TROCAR, SMOOTH, .062X5"
00817906029796K-WIRE, S. TROCAR, SMOOTH, .045X6"
00817906029789K-WIRE, S. TROCAR, SMOOTH, .045X5"
008179060297721.6MMX9" SINGLE TROCAR, SMOOTH, K-WIRE
008179060297652.2MMX9" SINGLE TROCAR, SMOOTH, STEINMANN PIN
008179060297585MS, JONES SCREW TAP, Ø6.0
008179060297415MS, JONES SCREW TAP, Ø5.5
008179060297345MS, JONES SCREW TAP, Ø4.5
008179060297275MS, CANNULATED JONES DRILL, Ø4.5
008179060297105MS, CANNULATED JONES DRILL, Ø3.5
008179060297035MS, SMALL SCREW DRILL, Ø1.9
008179060296975MS, SMALL SCREW DRILL, Ø1.6
008179060296805MS, T25 DRIVER, CANNULATED, AO
008179060296735MS, T15 DRIVER, CANNULATED, AO
008179060296665MS, T7 DRIVER, SOLID, AO
008179060296592.5 mm Drill Bit
008179060296422.0 mm Drill Bit
00817906029635Olive Wire .045 x 2.5"
00817906029628T-8 Driver Bit
00817906029611T-8 Driver Bit
00817906029604Reamer, 2.9 mm Diameter, Non-Sterile
00817906029598Reamer, 2.4 mm Diameter, Non-Sterile
00817906029581.045 x 4.0 in. K-wire, double diamond, Non-Sterile
00810021861302AFX, Lag Guide, Ø1.9
00810021861296AFX, Lag Guide, Ø2.5
00810021861289NL Drill Guide, 2.5 & 3.5, Assy
00810021861272NL Drill Guide, 1.9 & 2.7, Assy
00810021861265Lag Screw Sizer, X-Small
00810021861258LAG SCREW SIZER, 9" WIRE
00810021861241LAG SCREW SIZER, 6" WIRE
00810021861234LAG SCREW WIRE GUIDE, Ø6.7

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