Locking Proximal Femur 00-1050-8004

GUDID 00841132130216

4.5mm 80° DFOS Plate, 5° Flare, No Offset, 4 Hole

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 00841132130216
• NIH Device Record Key: c6129bec-7dfa-4908-acb5-afd769b061da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking Proximal Femur
• Version Model Number: 00-1050-8004
• Catalog Number: 00-1050-8004
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• 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	00841132130216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111086

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: 2016-10-31

On-Brand Devices [Locking Proximal Femur]

• 00841132132753: LOCKING PROXIMAL FEMUR IMPLANT TRAY
• 00841132130391: ORTHOPEDIATRICS LID, VERTICAL HANDLES
• 00841132130384: TRAY 3: MODULAR TRAY FOR LOCKING PROXIMAL FEMORAL PLATE INSTRUMENTATION
• 00841132130377: TRAY 8: LOCKING PROXIMAL FEMUR PLATES (4.5 MM)
• 00841132130360: TRAY 7: LOCKING PROXIMAL FEMUR PLATES (3.5 MM)
• 00841132130353: TRAY 1: BASE TRAY FOR 3.5 T15 AND 4.5 T20 SCREW INSTRUMENTATION
• 00841132130315: LABEL FOR MODULAR SCREW CADDY, 3.5MM TRANS-PHYSEAL SCREWS
• 00841132130308: MODULAR SCREW CADDY 3.5MM BLOCK, TRANS-PHYSEAL SCREWS
• 00841132130254: 4.5mm 80° DFOS Plate, 5° Flare, No Offset, 8 Hole
• 00841132130247: 4.5mm 80° DFOS Plate, 5° Flare, No Offset, 7 Hole
• 00841132130230: 4.5mm 80° DFOS Plate, 5° Flare, No Offset, 6 Hole
• 00841132130223: 4.5mm 80° DFOS Plate, 5° Flare, No Offset, 5 Hole
• 00841132130216: 4.5mm 80° DFOS Plate, 5° Flare, No Offset, 4 Hole
• 00841132130209: 4.5mm 80° DFOS Plate, 5° Flare, No Offset, 3 Hole
• 00841132130193: 3.5mm 80° DFOS Plate, 5° Flare, No Offset, 8 Hole
• 00841132130186: 3.5mm 80° DFOS Plate, 5° Flare, No Offset, 7 Hole
• 00841132130179: 3.5mm 80° DFOS Plate, 5° Flare, No Offset, 6 Hole
• 00841132130162: 3.5mm 80° DFOS Plate, 5° Flare, No Offset, 5 Hole
• 00841132130155: 3.5mm 80° DFOS Plate, 5° Flare, No Offset, 4 Hole
• 00841132130148: 3.5mm 80° DFOS Plate, 5° Flare, No Offset, 3 Hole
• 00841132130131: 4.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 8 Hole
• 00841132130124: 4.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 7 Hole
• 00841132130117: 4.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 6 Hole
• 00841132130100: 4.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 5 Hole
• 00841132130094: 4.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 4 Hole
• 00841132130087: 4.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 3 Hole
• 00841132130070: 4.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 8 Hole
• 00841132130063: 4.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 7 Hole
• 00841132130056: 4.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 6 Hole
• 00841132130049: 4.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 5 Hole
• 00841132130032: 4.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 4 Hole
• 00841132130025: 4.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 3 Hole
• 00841132130018: 4.5mm 90° DFOS Plate, 5° Flare, No Offset, 8 Hole
• 00841132130001: 4.5mm 90° DFOS Plate, 5° Flare, No Offset, 7 Hole
• 00841132129999: 4.5mm 90° DFOS Plate, 5° Flare, No Offset, 6 Hole
• 00841132129982: 4.5mm 90° DFOS Plate, 5° Flare, No Offset, 5 Hole
• 00841132129975: 4.5mm 90° DFOS Plate, 5° Flare, No Offset, 4 Hole
• 00841132129968: 4.5mm 90° DFOS Plate, 5° Flare, No Offset, 3 Hole
• 00841132129951: 3.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 8 Hole
• 00841132129944: 3.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 7 Hole
• 00841132129937: 3.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 6 Hole
• 00841132129920: 3.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 5 Hole
• 00841132129913: 3.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 4 Hole
• 00841132129906: 3.5mm 90° DFOS Plate, 18° Flare, 8mm Offset, 3 Hole
• 00841132129890: 3.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 8 Hole
• 00841132129883: 3.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 7 Hole
• 00841132129876: 3.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 6 Hole
• 00841132129869: 3.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 5 Hole
• 00841132129852: 3.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 4 Hole
• 00841132129845: 3.5mm 90° DFOS Plate, 18° Flare, 4mm Offset, 3 Hole