10312H

GUDID 00816342023788

28 Knotless Push-In Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342023788
• NIH Device Record Key: ecd2d704-0000-41d2-85fb-1f883e81ddc7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 10312H
• Catalog Number: 10312H
• 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: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com
• Phone: 9417557965
• Email: ParcusCS@Anika.com

Device Dimensions

• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter
• Outer Diameter: 2.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342023788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113730

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, 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: 2021-12-17
• Device Publish Date: 2021-12-09

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