Orthex Tool CB-075B

GUDID 00841132177846

X-Ray Ball Bridge, Small Bone 75mm

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00841132177846
• NIH Device Record Key: 9642dbcf-b566-4a56-864d-93b7758d61c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Tool
• Version Model Number: CB-075B
• Catalog Number: CB-075B
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132177846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

[00841132177846]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

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• 00841132177853: X-Ray Ball Bridge, Small Bone 95mm
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• 00841132177839: X-Ray Ball Bridge, Small Bone 60mm
• 00841132180648: 2.0MM DIA. NEUTRAL & LOAD END GREEN/GOLD DRILL GUIDE
• 00841132179949: Drill Sleeve, SB 5.0x4.5x100mm
• 00841132179888: Wire Sleeve, SB 4.5x1.5x110mm
• 00841132179871: 4.8 drill sleeve, Short
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• 00841132178102: Orthex, Handle, AO Pull Adpt