PediPlate 00-1012-116

GUDID 00841132123683

O-PLATE 16mm

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132123683
• NIH Device Record Key: e775cec1-ea8f-44fe-9e26-b9d6e281dcf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediPlate
• Version Model Number: 00-1012-116
• Catalog Number: 00-1012-116
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132123683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090666

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-30

On-Brand Devices [PediPlate]

• 00841132123683: O-PLATE 16mm
• 00841132114124: 4.5MM X 36MM LP CANN SCREW, SS, FULL THD
• 00841132114117: 4.5MM X 32MM LP CANN SCREW, SS, FULL THD
• 00841132114100: 4.5MM X 28MM LP CANN SCREW, SS, FULL THD
• 00841132114094: 4.5MM X 24MM LP CANN SCREW, SS, FULL THD
• 00841132114087: 4.5MM X 20MM LP CANN SCREW, SS, FULL THD
• 00841132114070: 4.5MM X 16MM LP CANN SCREW, SS, FULL THD
• 00841132114063: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 36MM
• 00841132114056: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 35MM
• 00841132114049: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 34MM
• 00841132114032: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 32MM
• 00841132114025: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 30MM
• 00841132114018: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 28MM
• 00841132114001: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 26MM
• 00841132113998: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 25MM
• 00841132113981: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 24MM
• 00841132113974: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 22MM
• 00841132113967: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 20MM
• 00841132113950: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 18MM
• 00841132113943: 4.5MM SOLID SCREW, CANCELLOUS THREAD, 16MM
• 00841132113936: 4.5mm Cannulated Screw X 36mm Full Thread
• 00841132113929: 4.5mm Cannulated Screw X 32mm Full Thread
• 00841132113912: 4.5mm Cannulated Screw X 28mm Full Thread
• 00841132113905: 4.5mm Cannulated Screw X 24mm Full Thread
• 00841132113899: 4.5mm Cannulated Screw X 20mm Full Thread
• 00841132113882: 4.5mm Cannulated Screw X 16mm Full Thread
• 00841132113875: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 50MM
• 00841132113868: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 48MM
• 00841132113851: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 46MM
• 00841132113844: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 44MM
• 00841132113837: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 42MM
• 00841132113820: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 40MM
• 00841132113813: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 38MM
• 00841132113806: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 36MM
• 00841132113790: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 34MM
• 00841132113783: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 32MM
• 00841132113776: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 30MM
• 00841132113769: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 28MM
• 00841132113752: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 26MM
• 00841132113745: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 24MM
• 00841132113738: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 22MM
• 00841132113721: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 20MM
• 00841132113714: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 18MM
• 00841132113707: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 16MM
• 00841132113691: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 14MM
• 00841132113684: 3.5 MM CORTICAL SCREW, FULL THREAD, SIZE 12MM
• 00841132113677: 4.5mm CANNULATED SCREW, DELTA, 36mm
• 00841132113660: 4.5mm CANNULATED SCREW, DELTA, 32mm
• 00841132113653: 4.5mm CANNULATED SCREW, DELTA, 28mm
• 00841132113646: 4.5mm CANNULATED SCREW, DELTA, 24mm