Pediatric Nailing Platform Femur 00-1504-0950

GUDID 00840194415330

9mm x 500mm Adolescent Nail, Right

ORTHOPEDIATRICS CORP.

Femur nail

• Primary Device ID: 00840194415330
• NIH Device Record Key: 22c6215e-b412-40d7-a3bd-b0337db38ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Nailing Platform Femur
• Version Model Number: 00-1504-0950
• Catalog Number: 00-1504-0950
• 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: 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: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194415330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220679

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[00840194415330]

Moist Heat or Steam Sterilization

[00840194415330]

Moist Heat or Steam Sterilization

[00840194415330]

Moist Heat or Steam Sterilization

[00840194415330]

Moist Heat or Steam Sterilization

[00840194415330]

Moist Heat or Steam Sterilization

[00840194415330]

Moist Heat or Steam Sterilization

[00840194415330]

Moist Heat or Steam Sterilization

[00840194415330]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-09-16

On-Brand Devices [Pediatric Nailing Platform Femur]

• 00840194415620: 10mm x 20mm End Cap, Retaining
• 00840194415613: 10mm x 15mm End Cap, Retaining
• 00840194415606: 10mm x 10mm End Cap, Retaining
• 00840194415590: 10mm x 5mm End Cap, Retaining
• 00840194415583: 10mm x 0mm End Cap, Flush, Retaining
• 00840194415576: 12mm x 500mm Adolescent Nail, Right
• 00840194415569: 12mm x 480mm Adolescent Nail, Right
• 00840194415552: 12mm x 460mm Adolescent Nail, Right
• 00840194415545: 12mm x 440mm Adolescent Nail, Right
• 00840194415538: 12mm x 500mm Adolescent Nail, Left
• 00840194415521: 12mm x 480mm Adolescent Nail, Left
• 00840194415514: 12mm x 460mm Adolescent Nail, Left
• 00840194415507: 12mm x 440mm Adolescent Nail, Left
• 00840194415491: 11mm x 500mm Adolescent Nail, Right
• 00840194415484: 11mm x 480mm Adolescent Nail, Right
• 00840194415477: 11mm x 460mm Adolescent Nail, Right
• 00840194415460: 11mm x 440mm Adolescent Nail, Right
• 00840194415453: 11mm x 500mm Adolescent Nail, Left
• 00840194415446: 11mm x 480mm Adolescent Nail, Left
• 00840194415439: 11mm x 460mm Adolescent Nail, Left
• 00840194415422: 11mm x 440mm Adolescent Nail, Left
• 00840194415415: 10mm x 500mm Adolescent Nail, Right
• 00840194415408: 10mm x 480mm Adolescent Nail, Right
• 00840194415392: 10mm x 460mm Adolescent Nail, Right
• 00840194415385: 10mm x 440mm Adolescent Nail, Right
• 00840194415378: 10mm x 500mm Adolescent Nail, Left
• 00840194415361: 10mm x 480mm Adolescent Nail, Left
• 00840194415354: 10mm x 460mm Adolescent Nail, Left
• 00840194415347: 10mm x 440mm Adolescent Nail, Left
• 00840194415330: 9mm x 500mm Adolescent Nail, Right
• 00840194415323: 9mm x 480mm Adolescent Nail, Right
• 00840194415316: 9mm x 460mm Adolescent Nail, Right
• 00840194415309: 9mm x 440mm Adolescent Nail, Right
• 00840194415293: 9mm x 500mm Adolescent Nail, Left
• 00840194415286: 9mm x 480mm Adolescent Nail, Left
• 00840194415279: 9mm x 460mm Adolescent Nail, Left
• 00840194415262: 9mm x 440mm Adolescent Nail, Left
• 00840194415255: 9mm x 20mm End Cap, Retaining
• 00840194415248: 9mm x 15mm End Cap, Retaining
• 00840194415231: 9mm x 10mm End Cap, Retaining
• 00840194415224: 9mm x 5mm End Cap, Retaining
• 00840194415217: 9mm x 0mm End Cap, Flush, Retaining
• 00840194405669: 2.0 X 450mm Smooth Wire
• 00840194405621: PNP Extraction Chisel
• 00840194405614: PNP Adolescent Hook Extractor
• 00840194405607: PNP Child Hook Extractor
• 00840194405577: PNP Screw Easy Out
• 00840194405560: PNP Screw Easy Off
• 00840194405553: PNP End Cap Easy Out
• 00840194405508: Pedinail Conical Cannulated Extractor - Slap Hammer