Locking Cannulated Blade Plate System 00-1200-4515

GUDID 00841132110225

90 DEGREE CANNULATED ADOLESCENT OSTEOTOMY PLATE 45MM X 14MM OFFSET X 6.5MM

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132110225
• NIH Device Record Key: aa7c90f3-099e-4c9b-8bb2-a740e67bb710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking Cannulated Blade Plate System
• Version Model Number: 00-1200-4515
• Catalog Number: 00-1200-4515
• 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	00841132110225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110959

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: 2015-09-24

On-Brand Devices [Locking Cannulated Blade Plate System]

• 00841132137116: 110° CANN ADOL BLADE PLATE 70MM X 10MM OFFSET X 4 HOLE
• 00841132137109: 110° CANN ADOL BLADE PLATE 65MM X 10MM OFFSET X 4 HOLE
• 00841132137093: 110° CANN ADOL BLADE PLATE 60MM X 10MM OFFSET X 4 HOLE
• 00841132137086: 110° CANN ADOL BLADE PLATE 55MM X 10MM OFFSET X 4 HOLE
• 00841132137079: 110° CANN ADOL BLADE PLATE 50MM X 10MM OFFSET X 4 HOLE
• 00841132137062: 110° CANN ADOL BLADE PLATE 45MM X 10MM OFFSET X 4 HOLE
• 00841132137055: 110° CANN ADOL BLADE PLATE 40MM X 10MM OFFSET X 4 HOLE
• 00841132137048: 110° CANN ADOL BLADE PLATE 35MM X 10MM OFFSET X 4 HOLE
• 00841132137031: 110° CANN ADOL BLADE PLATE 30MM X 10MM OFFSET X 4 HOLE
• 00841132137024: 110° CANN ADOL BLADE PLATE 25MM X 10MM OFFSET X 4 HOLE
• 00841132137017: 110° CANN ADOL BLADE PLATE 20MM X 10MM OFFSET X 4 HOLE
• 00841132137000: 110° CANN ADOL BLADE PLATE 70MM X 14MM OFFSET X 4 HOLE
• 00841132136997: 110° CANN ADOL BLADE PLATE 65MM X 14MM OFFSET X 4 HOLE
• 00841132136980: 110° CANN ADOL BLADE PLATE 60MM X 14MM OFFSET X 4 HOLE
• 00841132136973: 110° CANN ADOL BLADE PLATE 55MM X 14MM OFFSET X 4 HOLE
• 00841132136966: 110° CANN ADOL BLADE PLATE 50MM X 14MM OFFSET X 4 HOLE
• 00841132136959: 110° CANN ADOL BLADE PLATE 45MM X 14MM OFFSET X 4 HOLE
• 00841132136942: 110° CANN ADOL BLADE PLATE 40MM X 14MM OFFSET X 4 HOLE
• 00841132136935: 110° CANN ADOL BLADE PLATE 35MM X 14MM OFFSET X 4 HOLE
• 00841132136928: 110° CANN ADOL BLADE PLATE 30MM X 14MM OFFSET X 4 HOLE
• 00841132136911: 110° CANN ADOL BLADE PLATE 25MM X 14MM OFFSET X 4 HOLE
• 00841132136904: 110° CANN ADOL BLADE PLATE 20MM X 14MM OFFSET X 4 HOLE
• 00841132136898: 110° CANN ADOL BLADE PLATE 70MM X 6MM OFFSET X 4 HOLE
• 00841132136881: 110° CANN ADOL BLADE PLATE 65MM X 6MM OFFSET X 4 HOLE
• 00841132136874: 110° CANN ADOL BLADE PLATE 60MM X 6MM OFFSET X 4 HOLE
• 00841132136867: 110° CANN ADOL BLADE PLATE 55MM X 6MM OFFSET X 4 HOLE
• 00841132136850: 110° CANN ADOL BLADE PLATE 50MM X 6MM OFFSET X 4 HOLE
• 00841132136843: 110° CANN ADOL BLADE PLATE 45MM X 6MM OFFSET X 4 HOLE
• 00841132136836: 110° CANN ADOL BLADE PLATE 40MM X 6MM OFFSET X 4 HOLE
• 00841132136829: 110° CANN ADOL BLADE PLATE 35MM X 6MM OFFSET X 4 HOLE
• 00841132136812: 110° CANN ADOL BLADE PLATE 30MM X 6MM OFFSET X 4 HOLE
• 00841132136805: 110° CANN ADOL BLADE PLATE 25MM X 6MM OFFSET X 4 HOLE
• 00841132136799: 110° CANN ADOL BLADE PLATE 20MM X 6MM OFFSET X 4 HOLE
• 00841132136782: 90° CANN ADOL BLADE PLATE 35MM X 14MM OFFSET X 4 HOLE
• 00841132136775: 90° CANN ADOL BLADE PLATE 30MM X 14MM OFFSET X 4 HOLE
• 00841132136768: 90° CANN ADOL BLADE PLATE 25MM X 14MM OFFSET X 4 HOLE
• 00841132136751: 90° CANN ADOL BLADE PLATE 20MM X 14MM OFFSET X 4 HOLE
• 00841132136744: 90° CANN ADOL BLADE PLATE 35MM X 6MM OFFSET X 4 HOLE
• 00841132136737: 90° CANN ADOL BLADE PLATE 30MM X 6MM OFFSET X 4 HOLE
• 00841132136720: 90° CANN ADOL BLADE PLATE 25MM X 6MM OFFSET X 4 HOLE
• 00841132136713: 90° CANN ADOL BLADE PLATE 20MM X 6MM OFFSET X 4 HOLE
• 00841132123713: 90 Deg. Locking Cannulated Infant Blade 35mm x 12mm x 3 hole
• 00841132123706: 90 Deg. Locking Cannulated Infant Blade 30mm x 12mm x 3 hole
• 00841132123690: 90 Deg. Locking Cannulated Infant Blade 25mm x 12mm x 3 hole
• 00841132110409: 130 Deg Cannulated Adolescent Blade Plate 80mm x 0mm x 4 Hole
• 00841132110393: 130 Deg Cannulated Adolescent Blade Plate 75mm x 0mm x 4 Hole
• 00841132110386: 130 Deg Cannulated Adolescent Blade Plate 70mm x 0mm x 4 Hole
• 00841132110379: 130 Deg Cannulated Adolescent Blade Plate 65mm x 0mm x 4 Hole
• 00841132110362: 130 Deg Cannulated Adolescent Blade Plate 60mm x 0mm x 4 Hole
• 00841132110355: 130 Deg Cannulated Adolescent Blade Plate 55mm x 0mm x 4 Hole