PediNail Intramedullary Platform 00-1506-4058

GUDID 00841132149119

5.0MM X 58MM FULLY THREADED INTERLOCKING SCREW, 4.3MM CORE

ORTHOPEDIATRICS CORP.

Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: 00841132149119
• NIH Device Record Key: ea00f00b-18af-4564-bd4d-c920a55b29f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediNail Intramedullary Platform
• Version Model Number: 00-1506-4058
• Catalog Number: 00-1506-4058
• 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: true
• 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: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com
• Phone: +1(574)268-6379
• Email: Rzorn@OrthoPediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132149119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172583

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-31

On-Brand Devices [PediNail Intramedullary Platform]

• 00841132150566: 10MM X 20MM END CAP
• 00841132150559: 10MM X 15MM END CAP
• 00841132150542: 10MM X 10MM END CAP
• 00841132150535: 10MM X 5MM END CAP
• 00841132150528: 10MM X 0MM END CAP, FLUSH
• 00841132150511: ADOLESCENT RIGHT NAILS CASE WITH LID
• 00841132150504: ADOLESCENT LEFT NAILS CASE WITH LID
• 00841132150498: CHILD RIGHT NAILS CASE WITH LID
• 00841132150481: CHILD LEFT NAILS CASE WITH LID
• 00841132150474: IM REAMER CASE WITH LID
• 00841132150467: INSTRUMENT CASE 2 WITH LID
• 00841132150450: INSTRUMENT CASE 1 WITH LID
• 00841132150443: SCREW/END CAP CADDY WITH LID
• 00841132150436: IMPACTOR, SOLID
• 00841132150429: 5.0MM DRILL SLEEVE OBTURATOR
• 00841132150412: 4.3MM DRILL SLEEVE OBTURATOR
• 00841132150405: 4.5MM DRILL SLEEVE OBTURATOR
• 00841132150399: 3.8MM DRILL SLEEVE OBTURATOR
• 00841132150382: T-HANDLE HEX DRIVER, CANNULATED
• 00841132150375: EXTRACTOR
• 00841132150368: ADOLESCENT NAIL EXTRACTION ADAPTOR
• 00841132150351: CHILD NAIL EXTRACTION ADAPTOR
• 00841132150344: EXPLANT DRIVER SLEEVE
• 00841132150337: EXPLANT DRIVER SHAFT, 3.5MM, AO
• 00841132150320: CAPTURED SCREW DRIVER SLEEVE, LONG
• 00841132150313: CAPTURED SCREW DRIVER SLEEVE, SHORT
• 00841132150306: CAPTURED SCREW DRIVER SHAFT, 3.5MM, AO, LONG
• 00841132150290: CAPTURED SCREW DRIVER SHAFT, 3.5MM, AO, SHORT
• 00841132150283: TAPERED SCREW DRIVER, 3.5MM, AO, LONG
• 00841132150276: TAPERED SCREW DRIVER, 3.5MM, AO, SHORT
• 00841132150269: SCALE, 10-100MM
• 00841132150252: DEPTH GAUGE, OUTER TUBE
• 00841132150245: 5.0MM RECON SCREW STEPPED DRILL BIT, CALIBRATED, AO
• 00841132150238: 4.3MM DRILL BIT, CALIBRATED, AO
• 00841132150221: 4.3MM DRILL BIT, SHORT, AO
• 00841132150214: 4.5MM RECON SCREW STEPPED DRILL BIT, CALIBRATED, AO
• 00841132150207: 3.8MM DRILL BIT, CALIBRATED, AO
• 00841132150191: 3.8MM DRILL BIT, SHORT, AO
• 00841132150184: INNER DRILL SLEEVE, 5.0MM DRILL
• 00841132150177: INNER DRILL SLEEVE, 4.3MM DRILL
• 00841132150160: INNER DRILL SLEEVE, 4.5MM DRILL
• 00841132150153: INNER DRILL SLEEVE, 3.8MM DRILL
• 00841132150146: OUTER SCREW SLEEVE
• 00841132150139: SHEATH REMOVAL TOOL
• 00841132150122: GUIDE ROD OBTURATOR
• 00841132150115: 14.0MM MODULAR REAMER HEAD
• 00841132150108: 13.5MM MODULAR REAMER HEAD
• 00841132150092: 13.0MM MODULAR REAMER HEAD
• 00841132150085: 12.5MM MODULAR REAMER HEAD
• 00841132150078: 7.0MM EN BLOC IM REAMER