Falcon 907000-0820

GUDID 00811714035130

Falcon

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714035130
• NIH Device Record Key: 6f7321cc-1919-455f-b243-cbec4fbd68bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Falcon
• Version Model Number: 907000-0820
• Catalog Number: 907000-0820
• Company DUNS: 002745858
• Company Name: RESPONSIVE ORTHOPEDICS LLC
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00811714035130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202569

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [Falcon]

• 00811714035178: Falcon
• 00811714035161: Falcon
• 00811714035130: Falcon
• 00811714035109: Falcon
• 00811714035376: Falcon 10 mm Reamer
• 00811714035215: Falcon 9 mm Sizer
• 00811714035208: Falcon 8 mm Sizer
• 00811714035192: Falcon 7 mm Sizer
• 00811714034881: Falcon 9.5 mm Reamer
• 00811714034874: Falcon 9 mm Reamer
• 00811714034867: Falcon 8.5 mm Reamer
• 00811714034850: Falcon 8 mm Reamer
• 00811714034843: Falcon 7.5 mm Reamer
• 00811714034836: Falcon 7mm Reamer