PediLoc Tibial Plate 00-0903-3406

GUDID 00841132104064

3.5mm WIDE MEDIAL DISTAL TIBIAL LOCKING COMPRESSION PLATE, 6 HOLE PLATE RIGHT

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132104064
• NIH Device Record Key: 2610e07b-2a7c-49a9-8d84-558576883fa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediLoc Tibial Plate
• Version Model Number: 00-0903-3406
• Catalog Number: 00-0903-3406
• 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	00841132104064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100240

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: 2015-08-01

On-Brand Devices [PediLoc Tibial Plate]

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• 00841132111130: 3.5mm Locking Cortical Screw with T15 Hexalobe, Size 68mm
• 00841132111123: 3.5mm Locking Cortical Screw with T15 Hexalobe, Size 66mm
• 00841132111116: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 65MM
• 00841132111109: 3.5mm Locking Cortical Screw with T15 Hexalobe, Size 64mm
• 00841132111093: 3.5mm Locking Cortical Screw with T15 Hexalobe, Size 62mm
• 00841132111086: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 60MM
• 00841132111079: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 58MM
• 00841132111062: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 56MM
• 00841132111055: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 55MM
• 00841132111048: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 54MM
• 00841132111031: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 52MM
• 00841132111024: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 50MM
• 00841132111017: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 48MM
• 00841132111000: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 46MM
• 00841132110997: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 45MM
• 00841132110980: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 44MM
• 00841132110973: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 42MM
• 00841132110966: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 40MM
• 00841132110959: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 38MM
• 00841132110942: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 36MM
• 00841132110935: 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 35MM
• 00841132110928: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 34MM
• 00841132110911: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 32MM
• 00841132110904: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 30MM
• 00841132110898: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 28MM
• 00841132110881: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 26MM
• 00841132110874: 3.5mm Locking Cortical Screw with T15 Hexalobe, Size 25mm
• 00841132110867: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 24MM
• 00841132110850: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 22MM
• 00841132110843: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 20MM
• 00841132110836: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 18MM
• 00841132110829: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 16MM
• 00841132110812: 3.5mm Locking Cortical Screw with T15 Hexalobe, Size 15mm
• 00841132110805: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 14MM
• 00841132110799: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 12MM
• 00841132110782: 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 10MM
• 00841132110775: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 70MM
• 00841132110768: 3.5mm Self Tapping Cortical Screw with T15 Hexalobe, Size 68mm
• 00841132110751: 3.5mm Self Tapping Cortical Screw with T15 Hexalobe, Size 66mm
• 00841132110744: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 65MM
• 00841132110737: 3.5mm Self Tapping Cortical Screw with T15 Hexalobe, Size 64mm
• 00841132110720: 3.5mm Self Tapping Cortical Screw with T15 Hexalobe, Size 62mm
• 00841132110713: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 60MM
• 00841132110706: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 58MM
• 00841132110690: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 56MM
• 00841132110683: 3.5MM CORTICAL SCREW, T15 HEXALOBE, SELF TAPPING, 55MM
• 00841132110676: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 54MM
• 00841132110669: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 52MM
• 00841132110652: 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 50MM