Cortical Screw 32455-52

GUDID 09120034301940

Cortical Screw, D=4.5mm, L=52mm

I.T.S. GmbH

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 09120034301940
• NIH Device Record Key: eea72d2f-8909-4912-8573-f752792a1897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortical Screw
• Version Model Number: 32455-52
• Catalog Number: 32455-52
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120034301940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063166

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

[09120034301940]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-09-05

On-Brand Devices [Cortical Screw]

• 09120069816006: Cortical Screw, D=2.7mm, L=15mm
• 09120069815993: Cortical Screw, D=2.7mm, L=13mm
• 09120047309391: Cortical Screw, D=2.7mm, L=7mm
• 09120047309384: Cortical Screw, D=2.7mm, L=6mm
• 09120047305430: Cortical Screw, D=1.5mm, L=26mm
• 09120047305423: Cortical Screw, D=1.5mm, L=24mm
• 09120047305416: Cortical Screw, D=1.5mm, L=22mm
• 09120047305409: Cortical Screw, D=1.5mm, L=18mm
• 09120047305393: Cortical Screw, D=1.5mm, L=16mm
• 09120047305386: Cortical Screw, D=1.5mm, L=15mm
• 09120047305379: Cortical Screw, D=1.5mm, L=14mm
• 09120047305362: Cortical Screw, D=1.5mm, L=13mm
• 09120047305355: Cortical Screw, D=1.5mm, L=12mm
• 09120047305348: Cortical Screw, D=1.5mm, L=11mm
• 09120047305331: Cortical Screw, D=1.5mm, L=10mm
• 09120047305324: Cortical Screw, D=1.5mm, L=9mm
• 09120047305317: Cortical Screw, D=1.5mm, L=8mm
• 09120047305300: Cortical Screw, D=1.5mm, L=7mm
• 09120047305294: Cortical Screw, D=1.5mm, L=6mm
• 09120047305287: Cortical Screw, D=1.5mm, L=5mm
• 09120047304006: Cortical Screw, D=1.5mm, L=20mm
• 09120047302972: Cortical Screw, D=6.5mm, L=120mm
• 09120047302965: Cortical Screw, D=6.5mm, L=115mm
• 09120047302958: Cortical Screw, D=6.5mm, L=110mm
• 09120047302941: Cortical Screw, D=6.5mm, L=105mm
• 09120047302934: Cortical Screw, D=6.5mm, L=96mm
• 09120047302927: Cortical Screw, D=6.5mm, L=92mm
• 09120047302910: Cortical Screw, D=6.5mm, L=68mm
• 09120047302873: Cortical Screw, D=6.5mm, L=88mm
• 09120047302866: Cortical Screw, D=6.5mm, L=84mm
• 09120047302859: Cortical Screw, D=6.5mm, L=80mm
• 09120047302842: Cortical Screw, D=6.5mm, L=76mm
• 09120047302835: Cortical Screw, D=6.5mm, L=72mm
• 09120047302828: Cortical Screw, D=6.5mm, L=64mm
• 09120047302811: Cortical Screw, D=6.5mm, L=56mm
• 09120047302804: Cortical Screw, D=6.5mm, L=52mm
• 09120047302798: Cortical Screw, D=6.5mm, L=44mm
• 09120047302781: Cortical Screw, D=6.5mm, L=40mm
• 09120047302774: Cortical Screw, D=6.5mm, L=48mm
• 09120047302583: Cortical Screw, D=3.5mm, L=120mm
• 09120047302576: Cortical Screw, D=3.5mm, L=115mm
• 09120047302569: Cortical Screw, D=3.5mm, L=110mm
• 09120047302552: Cortical Screw, D=3.5mm, L=105mm
• 09120047302545: Cortical Screw, D=3.5mm, L=100mm
• 09120047302538: Cortical Screw, D=3.5mm, L=95mm
• 09120047302521: Cortical Screw, D=3.5mm, L=90mm
• 09120047302514: Cortical Screw, D=3.5mm, L=85mm
• 09120047302507: Cortical Screw, D=3.5mm, L=80mm
• 09120047302484: Cortical Screw, D=3.5mm, L=75mm
• 09120047302217: Cortical Screw, D=6.5mm, L=100mm