Locking Proximal Femur Plate System 00-0907-4520

GUDID 00841132111420

4.5mm SELF TAPPING CORTICAL SCREW, 20mm

ORTHOPEDIATRICS CORP.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00841132111420
• NIH Device Record Key: 7a0d4af7-f993-4e1b-9887-e57cdaa85398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking Proximal Femur Plate System
• Version Model Number: 00-0907-4520
• Catalog Number: 00-0907-4520
• 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
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• 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	00841132111420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111086

FDA Product Code

• HWC: Screw, 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: 2015-09-24

On-Brand Devices [Locking Proximal Femur Plate System]

• 00841132124406: 130° X 3.5MM INFANT PLATE, 4-HOLE
• 00841132124390: 130° X 3.5MM INFANT PLATE, 3-HOLE
• 00841132124383: 130° X 3.5MM INFANT PLATE, 2-HOLE
• 00841132124376: 110° X 3.5MM INFANT PLATE, 4-HOLE, 6MM OFFSET
• 00841132124369: 110° X 3.5MM INFANT PLATE, 3-HOLE, 6MM OFFSET
• 00841132124352: 110° X 3.5MM INFANT PLATE, 2-HOLE, 6MM OFFSET
• 00841132124345: 90° X 3.5MM INFANT PLATE, 4-HOLE, 6MM OFFSET
• 00841132124338: 90° X 3.5MM INFANT PLATE, 3-HOLE, 6MM OFFSET
• 00841132124321: 90° X 3.5MM INFANT PLATE, 2-HOLE, 6MM OFFSET
• 00841132123928: 140º X 4.5MM PLATE, 6 HOLE
• 00841132123911: 140º X 4.5MM PLATE, 5 HOLE
• 00841132123904: 140º X 4.5MM PLATE, 3 HOLE
• 00841132123898: 140º X 3.5MM PLATE, 6 HOLE
• 00841132123881: 140º X 3.5MM PLATE, 5 HOLE
• 00841132123874: 140º X 3.5MM PLATE, 4 HOLE
• 00841132123867: 140º X 3.5MM PLATE, 3 HOLE
• 00841132112212: 4.5mm CANNULATED LOCKING SCREW, 80mm
• 00841132112205: 4.5mm CANNULATED LOCKING SCREW, 75mm
• 00841132112199: 4.5mm CANNULATED LOCKING SCREW, 70mm
• 00841132112182: 4.5mm CANNULATED LOCKING SCREW, 65mm
• 00841132112175: 4.5mm CANNULATED LOCKING SCREW, 60mm
• 00841132112168: 4.5mm CANNULATED LOCKING SCREW, 58mm
• 00841132112151: 4.5mm CANNULATED LOCKING SCREW, 56mm
• 00841132112144: 4.5mm CANNULATED LOCKING SCREW, 55mm
• 00841132112137: 4.5mm CANNULATED LOCKING SCREW, 54mm
• 00841132112120: 4.5mm CANNULATED LOCKING SCREW, 52mm
• 00841132112113: 4.5mm CANNULATED LOCKING SCREW, 50mm
• 00841132112106: 4.5mm CANNULATED LOCKING SCREW, 48mm
• 00841132112090: 4.5mm CANNULATED LOCKING SCREW, 46mm
• 00841132112083: 4.5mm CANNULATED LOCKING SCREW, 45mm
• 00841132112076: 4.5mm CANNULATED LOCKING SCREW, 44mm
• 00841132112069: 4.5mm CANNULATED LOCKING SCREW, 42mm
• 00841132112052: 4.5mm CANNULATED LOCKING SCREW, 40mm
• 00841132112045: 4.5mm CANNULATED LOCKING SCREW, 38mm
• 00841132112038: 4.5mm CANNULATED LOCKING SCREW, 36mm
• 00841132112021: 4.5mm CANNULATED LOCKING SCREW, 34mm
• 00841132112014: 4.5mm CANNULATED LOCKING SCREW, 32mm
• 00841132112007: 4.5mm CANNULATED LOCKING SCREW, 30mm
• 00841132111994: 4.5mm CANNULATED LOCKING SCREW, 28mm
• 00841132111987: 4.5MM LOCKING SCREW, T20 HEXALOBE, SELF TAPPING, 90MM
• 00841132111970: 4.5MM LOCKING SCREW, T20 HEXALOBE, SELF TAPPING, 85MM
• 00841132111963: 4.5mm LOCKING SCREW, 80mm
• 00841132111956: 4.5mm LOCKING SCREW, 75mm
• 00841132111949: 4.5mm LOCKING SCREW, 70mm
• 00841132111932: 4.5mm LOCKING SCREW, 65mm
• 00841132111925: 4.5mm LOCKING SCREW, 60mm
• 00841132111918: 4.5mm LOCKING SCREW, 58mm
• 00841132111901: 4.5mm LOCKING SCREW, 56mm
• 00841132111895: 4.5mm LOCKING SCREW, 55mm
• 00841132111888: 4.5mm LOCKING SCREW, 54mm