FO Micro Screw System BTSC00164

GUDID 09353903003984

1.5 FO Micro Screw 18mm (Cannulated) 5/pkg

FIELD ORTHOPAEDICS PTY LTD

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID09353903003984
NIH Device Record Key494a0265-2815-4c21-a639-853c863a9c37
Commercial Distribution StatusIn Commercial Distribution
Brand NameFO Micro Screw System
Version Model NumberCPN000070
Catalog NumberBTSC00164
Company DUNS744008914
Company NameFIELD ORTHOPAEDICS PTY LTD
Device Count5
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter
Outer Diameter1.5 Millimeter
Length6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109353903002741 [Primary]
GS109353903003984 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

[09353903003984]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-07-17
Device Publish Date2020-05-19

On-Brand Devices [FO Micro Screw System]

093539030084840.6 Single-ended Trocar K-wire 70mm 1/pkg
093539030017820.6mm Pin Collet Insert
093539030020621.5 FO Micro Screw 10mm (Cannulated) 1/pkg
093539030020551.5 FO Micro Screw 9mm (Cannulated) 1/pkg
093539030020481.5 FO Micro Screw 8mm (Cannulated) 1/pkg
093539030020311.5 FO Micro Screw 7mm (Cannulated) 1/pkg
093539030020241.5 FO Micro Screw 6mm (Cannulated) 1/pkg
093539030004262.0 FO Guide Sleeve
093539030004191.6 FO Guide Sleeve
093539030004021.2 FO Guide Sleeve
093539030003961.0 FO Guide Sleeve
093539030003890.8 FO Guide Sleeve
093539030003720.6 FO Guide Sleeve
09353903000303FO Soft Tissue Protector
09353903001041FO Micro Screw Kit Tray and Lid
09353903000457FO Micro Screw Kit Lid
09353903000440FO Micro Screw Kit Tray
09353903002512FO Micro Cleaning Stylet
09353903000273FO Micro Cleaning Stylet
09353903001072FO Micro Screw Kit Lid
09353903001065FO Micro Screw Kit Tray
093539030042642.0 Double-ended Trocar Pin 150mm 5/pkg
093539030042571.6 Double-ended Trocar Pin 150mm 5/pkg
093539030042401.2 Double-ended Trocar K-wire 150mm 5/pkg
093539030042331.0 Double-ended Trocar K-wire 150mm 5/pkg
093539030042260.8 Double-ended Trocar K-wire 70mm 5/pkg
093539030042190.6 Double-ended Trocar K-wire 70mm 5/pkg
093539030042020.6 Single-ended Trocar K-wire 70mm 5/pkg
093539030017990.6mm Wire Collet Insert
093539030003652.0 Double-ended Trocar K-wire 150mm 5/pkg
093539030003581.6 Double-ended Trocar K-wire 150mm 5/pkg
093539030003411.2 Double-ended Trocar K-wire 150mm 5/pkg
093539030003341.0 Double-ended Trocar K-wire 150mm 5/pkg
093539030003270.8 Double-ended Trocar K-wire 70mm 5/pkg
093539030003100.6 Double-ended Trocar K-wire 70mm 5/pkg
093539030002280.6 Single-ended Trocar K-wire 70mm 5/pkg
093539030041962.0 FO Micro Screw 22mm (Cannulated) 5/pkg
093539030041892.0 FO Micro Screw 21mm (Cannulated) 5/pkg
093539030041722.0 FO Micro Screw 20mm (Cannulated) 5/pkg
093539030041652.0 FO Micro Screw 19mm (Cannulated) 5/pkg
093539030041582.0 FO Micro Screw 18mm (Cannulated) 5/pkg
093539030041412.0 FO Micro Screw 17mm (Cannulated) 5/pkg
093539030040281.5 FO Micro Screw 22mm (Cannulated) 5/pkg
093539030040111.5 FO Micro Screw 21mm (Cannulated) 5/pkg
093539030040041.5 FO Micro Screw 20mm (Cannulated) 5/pkg
093539030039911.5 FO Micro Screw 19mm (Cannulated) 5/pkg
093539030039841.5 FO Micro Screw 18mm (Cannulated) 5/pkg
093539030039771.5 FO Micro Screw 17mm (Cannulated) 5/pkg
093539030026662.0 FO Guide Sleeve
093539030026591.6 FO Guide Sleeve
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