PediLoc Locking Plate System 00-1050-4306

GUDID 00841132109564

4.5 mm CONTOUR LOCKING COMPRESSION FEMUR 6 HOLE PLATE LEFT

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132109564
• NIH Device Record Key: bc7b0732-cd9b-4352-bfa7-ab55891a8f8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediLoc Locking Plate System
• Version Model Number: 00-1050-4306
• Catalog Number: 00-1050-4306
• 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	00841132109564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083286

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: 2015-09-01

On-Brand Devices [PediLoc Locking Plate System]

• 00841132151037: 4.5mm Bowed Locking Compression Femur Plate, 18 Hole
• 00841132151020: 4.5mm Bowed Locking Compression Femur Plate, 16 Hole
• 00841132151013: 4.5mm Bowed Locking Compression Femur Plate, 14 Hole
• 00841132151006: 4.5mm Bowed Locking Compression Femur Plate, 12 Hole
• 00841132150993: 4.5mm Bowed Locking Compression Femur Plate, 10 Hole
• 00841132150986: 4.5mm Contour Locking Compression Femur Plate Left, Size 18
• 00841132150979: 4.5mm Contour Locking Compression Femur Plate Left, Size 16
• 00841132150962: 4.5mm Contour Locking Compression Femur Plate Left, Size 14
• 00841132150955: 4.5mm Contour Locking Compression Femur Plate Left, Size 12
• 00841132150948: 4.5mm Contour Locking Compression Femur Plate Left, Size 10
• 00841132150931: 4.5mm Contour Locking Compression Femur Plate Left, Size 8
• 00841132150924: 4.5mm Contour Locking Compression Femur Plate Left, Size 6
• 00841132150917: 4.5mm Contour Locking Compression Femur Plate Left, Size 4
• 00841132150900: 4.5mm Contour Locking Compression Femur Plate Right, Size 18
• 00841132150894: 4.5mm Contour Locking Compression Femur Plate Right, Size 16
• 00841132150887: 4.5mm Contour Locking Compression Femur Plate Right, Size 14
• 00841132150870: 4.5mm Contour Locking Compression Femur Plate Right, Size 12
• 00841132150863: 4.5mm Contour Locking Compression Femur Plate Right, Size 10
• 00841132150856: 4.5mm Contour Locking Compression Femur Plate Right, Size 8
• 00841132150849: 4.5mm Contour Locking Compression Femur Plate Right, Size 6
• 00841132150832: 4.5mm Contour Locking Compression Femur Plate Right, Size 4
• 00841132150825: 3.5mm Bowed Locking Compression Femur Plate, 18 Hole
• 00841132150818: 3.5mm Bowed Locking Compression Femur Plate, 16 Hole
• 00841132150801: 3.5mm Bowed Locking Compression Femur Plate, 14 Hole
• 00841132150795: 3.5mm Bowed Locking Compression Femur Plate, 12 Hole
• 00841132150788: 3.5mm Bowed Locking Compression Femur Plate, 10 Hole
• 00841132150771: 3.5mm Contour Locking Compression Femur Plate Left, Size 16
• 00841132150764: 3.5mm Contour Locking Compression Femur Plate Left, Size 14
• 00841132150757: 3.5mm Contour Locking Compression Femur Plate Left, Size 12
• 00841132150740: 3.5mm Contour Locking Compression Femur Plate Left, Size 10
• 00841132150733: 3.5mm Contour Locking Compression Femur Plate Left, Size 8
• 00841132150726: 3.5mm Contour Locking Compression Femur Plate Left, Size 6
• 00841132150719: 3.5mm Contour Locking Compression Femur Plate Left, Size 4
• 00841132150702: 3.5mm Contour Locking Compression Femur Plate Right, Size 16
• 00841132150696: 3.5mm Contour Locking Compression Femur Plate Right, Size 14
• 00841132150689: 3.5mm Contour Locking Compression Femur Plate Right, Size 12
• 00841132150672: 3.5mm Contour Locking Compression Femur Plate Right, Size 10
• 00841132150665: 3.5mm Contour Locking Compression Femur Plate Right, Size 8
• 00841132150658: 3.5mm Contour Locking Compression Femur Plate Right, Size 6
• 00841132150641: 3.5mm Contour Locking Compression Femur Plate Right, Size 4
• 00841132116456: 4.5MM LOCKING CORTICAL SCREW SIZE 90MM
• 00841132116449: 4.5MM LOCKING CORTICAL SCREW SIZE 85MM
• 00841132116432: 4.5MM LOCKING CORTICAL SCREW SIZE 80MM
• 00841132116425: 4.5MM LOCKING CORTICAL SCREW SIZE 75MM
• 00841132116418: 4.5MM LOCKING CORTICAL SCREW SIZE 70MM
• 00841132116401: 4.5MM LOCKING CORTICAL SCREW SIZE 65MM
• 00841132116395: 4.5MM LOCKING CORTICAL SCREW SIZE 60MM
• 00841132116388: 4.5MM LOCKING CORTICAL SCREW SIZE 58MM
• 00841132116371: 4.5MM LOCKING CORTICAL SCREW SIZE 56MM
• 00841132116364: 4.5MM LOCKING CORTICAL SCREW SIZE 54MM