Drive Rail System 22-3052

GUDID 00817867020634

CLAMP, 7-HOLE STACKED (5, 2)

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use

• Primary Device ID: 00817867020634
• NIH Device Record Key: 9fd5484d-dbbb-4da3-a1f9-51db7be9f9ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drive Rail System
• Version Model Number: 22-3052
• Catalog Number: 22-3052
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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	00817867020634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140822

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00817867020634]

Moist Heat or Steam Sterilization

[00817867020634]

Moist Heat or Steam Sterilization

[00817867020634]

Moist Heat or Steam Sterilization

[00817867020634]

Moist Heat or Steam Sterilization

[00817867020634]

Moist Heat or Steam Sterilization

[00817867020634]

Moist Heat or Steam Sterilization

[00817867020634]

Moist Heat or Steam Sterilization

[00817867020634]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [Drive Rail System]

• 00840194411219: 10mm Driver, Square Drive
• 00840194411158: Allen Wrench 3/16"
• 00817867021006: Hinge and Arch Tray
• 00817867020993: Hinge and Arch Screw Caddy
• 00817867020887: 3 mm 90° HEX WRENCH
• 00817867020856: Rail and Clamp Screw Caddy
• 00817867020849: Rail and Clamp Tray
• 00817867020832: Lid
• 00817867020825: 10 mm AND 13 mm OPEN END WRENCH
• 00817867020801: RAIL ASSEMBLY TOOL
• 00817867020795: 10 mm Ratchet Wrench
• 00817867020788: 3/16" HEX DRIVER
• 00817867020771: TORQUE T-HANDLE
• 00817867020764: 10 mm BOLT DRIVER
• 00817867020740: 10 mm COMBINATION WRENCH
• 00817867020733: 3/16" L-HEX DRIVER
• 00817867020672: SET SCREW
• 00817867020665: SCREW, CLAMP TO CARRIAGE
• 00817867020658: SCREW, SHORT, CLAMP TO CARRIAGE
• 00817867020641: CLAMP, 2-HOLE ANGLE
• 00817867020634: CLAMP, 7-HOLE STACKED (5, 2)
• 00817867020627: CLAMP, 5-HOLE IN-LINE
• 00817867020610: CLAMP, 5-HOLE STACKED (4, 1)
• 00817867020603: CLAMP, 4-HOLE IN-LINE
• 00817867020597: CLAMP, 3-HOLE IN-LINE
• 00817867020580: CLAMP, 2-HOLE IN-LINE
• 00817867020573: CLAMP, 1-HOLE
• 00817867020566: RAIL END CAP
• 00817867020559: CARRIAGE, RAIL ARCH
• 00817867020542: CARRIAGE, STANDARD
• 00817867020535: RAIL ENDCAP, ROTATING, 100 mm
• 00817867020528: DRIVE MECHANISM COVER