6.5 and 7.3mm Large Fragment Cannulated Screw System 00-1402-7390

GUDID 00840194406833

7.3mm Cannulated Screw, 32mm Long Thread,90mm SS

ORTHOPEDIATRICS CORP.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840194406833
• NIH Device Record Key: 43b4bd99-9284-4081-9ebd-d4c4c50e40c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6.5 and 7.3mm Large Fragment Cannulated Screw System
• Version Model Number: 00-1402-7390
• Catalog Number: 00-1402-7390
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00840194406833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190324

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

[00840194406833]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-01
• Device Publish Date: 2021-05-24

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