Locking Proximal Femur Plate System (LPF) 00-0907-1385

GUDID 00840194462983

130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 5 HOLE

ORTHOPEDIATRICS CORP.

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00840194462983
• NIH Device Record Key: 364149a0-16f1-43b9-8b96-f6c261d9006a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking Proximal Femur Plate System (LPF)
• Version Model Number: 00-0907-1385
• Catalog Number: 00-0907-1385
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194462983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111086

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

[00840194462983]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-06
• Device Publish Date: 2023-10-27

On-Brand Devices [Locking Proximal Femur Plate System (LPF)]

• 00841132123676: 140° X 4.5MM PLATE, 4 HOLE
• 00841132122440: Ø 1.6MM X Ø600MM GUIDE WIRE, BLUNT
• 00841132122433: 3.2MM X 200MM GUIDE WIRE, SMOOTH
• 00841132122426: 5.0MM X 200MM GUIDE WIRE, SMOOTH
• 00841132122419: 2.0MM X 230MM GUIDE WIRE, SMOOTH
• 00841132122402: 1.6MM X 230MM GUIDE WIRE, SMOOTH
• 00841132122396: 2.0MM X 150MM GUIDE WIRE, SMOOTH
• 00841132122389: 2.5MM X 200MM GUIDE WIRE, COCR
• 00841132122372: 2.0 MM X 150 MM GUIDE WIRE (COCR)
• 00841132122365: 2.0MM X 230MM GUIDE WIRE, COCR
• 00841132122358: 1.6MM X 230MM GUIDE WIRE, COCR
• 00841132122341: 2.0 MM X 150 MM GUIDE WIRE
• 00841132122334: T20 CANNULATED DRIVER
• 00841132122327: T15 CANNULATED DRIVER
• 00841132122310: 3.5 MM CANNULATED DRILL BIT
• 00841132122303: 2.9 MM CANNULATED DRILL BIT
• 00841132122297: 2.0MM X 230MM GUIDE WIRE
• 00841132122280: 1.6MM X 230MM GUIDE WIRE
• 00841132122273: T15 RETAINING DRIVER, SHORT
• 00841132122266: T15 HEXALOBE DRIVER, SHORT
• 00841132100042: 3.2MM X 200MM GUIDE WIRE, COCR
• 00841132100035: 90° X 3.5 MM VARUS PLATE 6 MM OFFSET, 3 HOLE
• 00840194462983: 130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 5 HOLE
• 00840194462976: 130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 4 HOLE
• 00840194462969: 130° X 4.5MM VALGUS PLATES, 6MM OFFSET, 3 HOLE
• 00840194462952: 130° X 4.5MM VALGUS PLATES,14MM OFFSET, 5 HOLE
• 00840194462945: 130° X 4.5MM VALGUS PLATES,14MM OFFSET, 4 HOLE
• 00840194462938: 130° X 4.5MM VALGUS PLATES,14MM OFFSET, 3 HOLE