PNP Tibia 00-1524-0015-S

GUDID 00840194469852

PNP 4.0mm x 15mm Fully Threaded Screw, Ti

ORTHOPEDIATRICS CORP.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00840194469852
• NIH Device Record Key: 8fae00d7-a6bc-4613-afd5-5a2532ed4066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNP Tibia
• Version Model Number: 00-1524-0015-S
• Catalog Number: 00-1524-0015-S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194469852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250623

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [PNP Tibia]

• 00840194466875: FLEXIBLE IM REAMER SHAFT 25IN
• 00840194466585: Large Head Pusher
• 00840194467162: 7.0mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467155: 6.5mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467148: 6.0mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467131: 7.0mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467124: 6.5mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467117: 6.0mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467100: NITINOL FLEX SHAFT, 635mm
• 00840194467094: NITINOL FLEX SHAFT, 435mm
• 00840194493895: 3.2mm x 330mm K-Wire, Threaded, 316L
• 00840194478366: PNP Tibia 12mm x 500mm Nail
• 00840194478359: PNP Tibia 12mm x 495mm Nail
• 00840194478342: PNP Tibia 12mm x 490mm Nail
• 00840194478335: PNP Tibia 12mm x 485mm Nail
• 00840194478328: PNP Tibia 12mm x 480mm Nail
• 00840194478311: PNP Tibia 12mm x 475mm Nail
• 00840194478304: PNP Tibia 12mm x 470mm Nail
• 00840194478298: PNP Tibia 12mm x 465mm Nail
• 00840194478281: PNP Tibia 12mm x 460mm Nail
• 00840194478274: PNP Tibia 12mm x 455mm Nail
• 00840194478267: PNP Tibia 12mm x 450mm Nail
• 00840194478250: PNP Tibia 12mm x 445mm Nail
• 00840194478243: PNP Tibia 12mm x 440mm Nail
• 00840194478236: PNP Tibia 12mm x 435mm Nail
• 00840194478229: PNP Tibia 12mm x 430mm Nail
• 00840194478212: PNP Tibia 12mm x 425mm Nail
• 00840194478205: PNP Tibia 12mm x 420mm Nail
• 00840194478199: PNP Tibia 12mm x 415mm Nail
• 00840194478182: PNP Tibia 12mm x 410mm Nail
• 00840194478175: PNP Tibia 12mm x 405mm Nail
• 00840194478168: PNP Tibia 12mm x 400mm Nail
• 00840194478151: PNP Tibia 12mm x 395mm Nail
• 00840194478144: PNP Tibia 12mm x 390mm Nail
• 00840194478137: PNP Tibia 12mm x 385mm Nail
• 00840194478120: PNP Tibia 12mm x 380mm Nail
• 00840194478113: PNP Tibia 12mm x 375mm Nail
• 00840194478106: PNP Tibia 12mm x 370mm Nail
• 00840194478090: PNP Tibia 12mm x 365mm Nail
• 00840194478083: PNP Tibia 12mm x 360mm Nail
• 00840194478076: PNP Tibia 12mm x 355mm Nail
• 00840194478069: PNP Tibia 12mm x 350mm Nail
• 00840194478052: PNP Tibia 12mm x 345mm Nail
• 00840194478045: PNP Tibia 12mm x 340mm Nail
• 00840194478038: PNP Tibia 12mm x 335mm Nail
• 00840194478021: PNP Tibia 12mm x 330mm Nail
• 00840194478014: PNP Tibia 12mm x 325mm Nail
• 00840194478007: PNP Tibia 12mm x 320mm Nail
• 00840194477994: PNP Tibia 12mm x 315mm Nail
• 00840194477987: PNP Tibia 12mm x 310mm Nail