Locking Fibular Plate, 7 holes

GUDID 00840118111928

implants for orthopedic bone fixation compatible with 2.7mm/3.5mm/4.0mm Screws

FLOWER ORTHOPEDICS CORPORATION

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118111928
• NIH Device Record Key: 3539744c-522a-4229-b939-feeb999a3036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking Fibular Plate, 7 holes
• Version Model Number: DLF 507
• Company DUNS: 078790947
• Company Name: FLOWER ORTHOPEDICS CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Height: 1.7 Millimeter
• Height: 1.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118111928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133102

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-08

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

• 00840118119610 - Flower Orthopedics: 2024-04-15 Screw Washer- For 2.7/3.5/4.0 Screws, 10mm
• 00840118119634 - Flower Orthopedics: 2024-04-15 2.7mm x 8mm Locking Screw
• 00840118119641 - Flower Orthopedics: 2024-04-15 2.7mm x 10mm Locking Screw
• 00840118119658 - Flower Orthopedics: 2024-04-15 2.7mm x 12mm Locking Screw
• 00840118119665 - Flower Orthopedics: 2024-04-15 2.7mm x 14mm Locking Screw
• 00840118119672 - Flower Orthopedics: 2024-04-15 2.7mm x 16mm Locking Screw
• 00840118119689 - Flower Orthopedics: 2024-04-15 2.7mm x 18mm Locking Screw
• 00840118119696 - Flower Orthopedics: 2024-04-15 2.7mm x 20mm Locking Screw