GUDID M685108030

45 Knotless AP Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: M685108030
• NIH Device Record Key: 12cbf2c4-bab6-4eb2-a42d-7762bc26a4be
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 10803
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M685108030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192824

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

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: 2020-05-25
• Device Publish Date: 2020-05-15

Devices Manufactured by PARCUS MEDICAL LLC

• 00816342022491 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025447 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025454 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025461 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025478 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025485 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025492 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025508 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm