CORVUS HTR-01-720423

GUDID 00841742100135

CORVUS Subtalar 10mm

HNM TOTAL RECON LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00841742100135
• NIH Device Record Key: cfc01734-92d1-4695-971b-b22aa19b810a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORVUS
• Version Model Number: HTR-01-720423
• Catalog Number: HTR-01-720423
• Company DUNS: 080024940
• Company Name: HNM TOTAL RECON LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841742100135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041936

FDA Product Code

• HWC: Screw, 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: 2016-05-17

On-Brand Devices [CORVUS]

• 00841742100159: CORVUS Subtalar 12mm
• 00841742100142: CORVUS Subtalar 11mm
• 00841742100135: CORVUS Subtalar 10mm
• 00841742100128: CORVUS Subtalar 9mm
• 00841742100111: CORVUS Subtalar 8mm
• 00841742100104: CORVUS Subtalar 6mm