Straight Osteo Plate, 5 Holes

GUDID 00840118101004

Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840118101004
• NIH Device Record Key: 09281160-0ce5-4111-8552-e62037480fef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Osteo Plate, 5 Holes
• Version Model Number: FRP 531
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 3.2 Millimeter
• Height: 3.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118101004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131657

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: 2015-09-15

On-Brand Devices [Straight Osteo Plate, 5 Holes]

• 00840118103299: Compatible with 2.7mm/3.5mm, implants for orthopedic bone fixation
• 00840118103176: Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
• 00840118102506: Compatible with 1.5mm/2.0mm/2.4mm screws, implants for orthopedic bone fixation
• 00840118101004: Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation