OrthoPediatrics Cannulated Screw System 01-1400-0046

GUDID 00841132168950

2.5mm Cannulated Tap

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132168950
• NIH Device Record Key: 6a94a809-781c-4cb7-a1fe-47ee1503d692
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPediatrics Cannulated Screw System
• Version Model Number: 01-1400-0046
• Catalog Number: 01-1400-0046
• 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: jjaskula@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132168950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190324

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-11
• Device Publish Date: 2019-09-03

On-Brand Devices [OrthoPediatrics Cannulated Screw System]

• 00841132172667: 6.5/7.3mm Cannulated-Screw Washer
• 00841132172643: 6.5mm Cannulated Screw, Fully Threaded, 148mm SS
• 00841132172629: 6.5mm Cannulated Screw, Fully Threaded, 145mm SS
• 00841132172605: 6.5mm Cannulated Screw, Fully Threaded, 142mm SS
• 00841132172582: 6.5mm Cannulated Screw, Fully Threaded, 138mm SS
• 00841132172575: 6.5mm Cannulated Screw, Fully Threaded, 136mm SS
• 00841132172568: 6.5mm Cannulated Screw, Fully Threaded, 135mm SS
• 00841132172551: 6.5mm Cannulated Screw, Fully Threaded, 134mm SS
• 00841132172544: 6.5mm Cannulated Screw, Fully Threaded, 132mm SS
• 00841132172537: 6.5mm Cannulated Screw, Fully Threaded, 130mm SS
• 00841132172520: 6.5mm Cannulated Screw, Fully Threaded, 128mm SS
• 00841132172513: 6.5mm Cannulated Screw, Fully Threaded, 126mm SS
• 00841132172506: 6.5mm Cannulated Screw, Fully Threaded, 125mm SS
• 00841132172490: 6.5mm Cannulated Screw, Fully Threaded, 124mm SS
• 00841132172483: 6.5mm Cannulated Screw, Fully Threaded, 122mm SS
• 00841132172476: 6.5mm Cannulated Screw, Fully Threaded, 120mm SS
• 00841132172421: 6.5mm Cannulated Screw, Fully Threaded, 112mm SS
• 00841132172414: 6.5mm Cannulated Screw, Fully Threaded, 110mm SS
• 00841132172407: 6.5mm Cannulated Screw, Fully Threaded, 108mm SS
• 00841132172391: 6.5mm Cannulated Screw, Fully Threaded, 106mm SS
• 00841132172377: 6.5mm Cannulated Screw, Fully Threaded, 104mm SS
• 00841132172360: 6.5mm Cannulated Screw, Fully Threaded, 102mm SS
• 00841132172346: 6.5mm Cannulated Screw, Fully Threaded, 98mm SS
• 00841132172315: 6.5mm Cannulated Screw, Fully Threaded, 94mm SS
• 00841132172308: 6.5mm Cannulated Screw, Fully Threaded, 92mm SS
• 00841132172261: 6.5mm Cannulated Screw, Fully Threaded, 85mm SS
• 00841132172230: 6.5mm Cannulated Screw, Fully Threaded, 80mm SS
• 00841132172209: 6.5mm Cannulated Screw, Fully Threaded, 75mm SS
• 00841132172193: 6.5mm Cannulated Screw, Fully Threaded, 74mm SS
• 00841132172186: 6.5mm Cannulated Screw, Fully Threaded, 72mm SS
• 00841132172155: 6.5mm Cannulated Screw, Fully Threaded, 66mm SS
• 00841132172124: 6.5mm Cannulated Screw, Fully Threaded, 62mm SS
• 00841132172117: 6.5mm Cannulated Screw, Fully Threaded, 60mm SS
• 00841132172087: 6.5mm Cannulated Screw, Fully Threaded, 55mm SS
• 00841132172070: 6.5mm Cannulated Screw, Fully Threaded, 54mm SS
• 00841132172063: 6.5mm Cannulated Screw, Fully Threaded, 52mm SS
• 00841132172056: 6.5mm Cannulated Screw, Fully Threaded, 50mm SS
• 00841132172049: 6.5mm Cannulated Screw, Fully Threaded, 48mm SS
• 00841132172025: 6.5mm Cannulated Screw, Fully Threaded, 45mm SS
• 00841132172018: 6.5mm Cannulated Screw, Fully Threaded, 44mm SS
• 00841132172001: 6.5mm Cannulated Screw, Fully Threaded, 42mm SS
• 00841132171998: 6.5mm Cannulated Screw, Fully Threaded, 40mm SS
• 00841132171981: 6.5mm Cannulated Screw, Fully Threaded, 38mm SS
• 00841132171974: 6.5mm Cannulated Screw, Fully Threaded, 36mm SS
• 00841132171950: 6.5mm Cannulated Screw, Fully Threaded, 34mm SS
• 00841132171936: 6.5mm Cannulated Screw, Fully Threaded, 30mm SS
• 00841132171912: 6.5mm Cannulated Screw, 32mm Long Thread, 148mm SS
• 00841132171899: 6.5mm Cannulated Screw, 32mm Long Thread, 145mm SS
• 00841132171882: 6.5mm Cannulated Screw, 32mm Long Thread, 144mm SS
• 00841132171875: 6.5mm Cannulated Screw, 32mm Long Thread, 142mm SS