CONTOURS LAPIDUS PLATING SYSTEM PSC35D18

GUDID 18054242513827

SCREW, 3.5MM X 1.25 X 18MM W/2.5MM HEX, BONE

ORTHOFIX SRL

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID18054242513827
NIH Device Record Keyc48cf60c-9ed2-4e65-95e2-2429405d2d73
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTOURS LAPIDUS PLATING SYSTEM
Version Model Number1
Catalog NumberPSC35D18
Company DUNS438793622
Company NameORTHOFIX SRL
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Dimensions

Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter
Width229 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242513827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

[18054242513827]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-01

On-Brand Devices [CONTOURS LAPIDUS PLATING SYSTEM]

18054242515210EMPTY INSTRUMENT TRAY,CONTOURS LPS
18054242514251TAP SLEEVE FOR 2.5MM AND 3.5MM DRILL BITS
180542425142442.7-4.0MM COUNTERSINK W/2MM TIP, AO
18054242514237SMALL PLATE BENDING IRON 5.5
18054242514183SCREW, LAPIDUS, 3.5MM X 1.25 X 32MM W/4.5MM X .75 LOCKING
18054242514176SCREW, LAPIDUS, 3.5MM X 1.25 X 30MM W/4.5MM X .75 LOCKING
18054242514169SCREW, LAPIDUS, 3.5MM X 1.25 X 12MM W/4.5MM X .75 LOCKING
18054242514152SCREW, LAPIDUS, 3.5MM X 1.25 X 28MM W/4.5MM X 7.5 LOCKING
18054242514145SCREW, LAPIDUS, 3.5MM X 1.25 X 26MM W/4.5MM X .75 LOCKING
18054242514138SCREW, LAPIDUS, 3.5MM X 1.25 X 24MM W/4.5MM X .75 LOCKING
18054242514121SCREW, LAPIDUS, 3.5MM X 1.25 X 22MM W/4.5MM X .75 LOCKING
18054242514114SCREW, LAPIDUS, 3.5MM X 1.25 X 20MM W/4.5MM X .75 LOCKING
18054242514107SCREW, LAPIDUS, 3.5MM X 1.25 X 18MM W/4.5MM X .75 LOCKING
18054242514091SCREW, LAPIDUS, 3.5MM X 1.25 X 16MM W/4.5MM X .75 LOCKING
18054242514084SCREW, LAPIDUS, 3.5MM X 1.25 X 14MM W/4.5MM X .75 LOCKING
18054242514077SCREW, LAPIDUS, 3.5MM X 1.25 X 32MM NON-LOCKING
18054242514060SCREW, LAPIDUS, 3.5MM X 1.25 X 30MM NON-LOCKING
18054242514053SCREW, LAPIDUS, 3.5MM X 1.25 X 12MM NON-LOCKING
18054242514046SCREW, LAPIDUS, 3.5MM X 1.25 X 28MM NON-LOCKING
18054242514039SCREW, LAPIDUS, 3.5MM X 1.25 X 24MM NON-LOCKING
18054242514022SCREW, LAPIDUS, 3.5MM X 1.25 X 22MM NON-LOCKING
18054242514015SCREW, LAPIDUS, 3.5MM X 1.25 X 20MM NON-LOCKING
18054242514008SCREW, LAPIDUS, 3.5MM X 1.25 X 18MM NON-LOCKING
18054242513995SCREW, LAPIDUS, 3.5MM X 1.25 X 16MM NON-LOCKING
18054242513988SCREW, LAPIDUS, 3.5MM X 1.25 X 14MM NON-LOCKING
18054242513971SCREW, LAPIDUS, 3.5MM X 1.25 X 22MM W/2.5MM HEX, BONE
18054242513964SCREW, LAPIDUS, 3.5MM X 1.25 X 48MM W/2.5MM HEX, BONE
18054242513957SCREW, LAPIDUS, 3.5MM X 1.25 X 46MM W/2.5MM HEX, BONE
18054242513940SCREW, LAPIDUS, 3.5MM X 1.25 X 44MM W/2.5MM HEX, BONE
18054242513933SCREW, LAPIDUS, 3.5MM X 1.25 X 42MM W/2.5MM HEX, BONE
18054242513926SCREW, 3.5MM X 1.25 X 14MM W/2.5MM HEX, BONE
18054242513919SCREW, 3.5MM X 1.25 X 12MM W/2.5MM HEX, BONE
18054242513902SCREW, 3.5MM X 1.25 X 10MM W/2.5MM HEX, BONE
18054242513896SCREW, LAPIDUS, 3.5MM X 1.25 X 50MM W/2.5MM HEX, BONE
18054242513872SCREW, LAPIDUS, 3.5MM X 1.25 X 40MM W/2.5MM HEX, BONE
18054242513865SCREW, LAPIDUS, 3.5MM X 1.25 X 35MM W/2.5MM HEX, BONE
18054242513858SCREW, LAPIDUS, 3.5MM X 1.25 X 30MM W/2.5MM HEX, BONE
18054242513841SCREW, LAPIDUS, 3.5MM X 1.25 X 25MM W/2.5MM HEX, BONE
18054242513834SCREW, LAPIDUS, 3.5MM X 1.25 X 20MM W/2.5MM HEX, BONE
18054242513827SCREW, 3.5MM X 1.25 X 18MM W/2.5MM HEX, BONE
18054242513810SCREW, 3.5MM X 1.25 X 16MM W/2.5MM HEX, BONE
18054242513797PLATE, LAPIDUS, RIGHT
18054242513780PLATE, LAPIDUS, LEFT
18054242513759SCREW, LAPIDUS, 3.5MM X 1.25 X 26MM NON-LOCKING
180542425137422.5 MM CANNULATED DRILL BIT, LAPIDUS SYSTEM
180542425137352.5 MM QUICK READ DRILL BIT, LAPIDUS SYSTEM
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