10005

GUDID 00816342020046

8x20mm Titanium Interference Screw with 1.5mm cannulation

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342020046
• NIH Device Record Key: 2a46c241-dcb6-4917-b1c5-3242ba2150b7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 10005
• Catalog Number: 10005
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com

Device Dimensions

• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342020046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083619

FDA Product Code

• HWC: Screw, fixation, bone
• 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: 2021-12-15
• Device Publish Date: 2021-12-07

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