X-Twist Biocomposite

GUDID 00816342025478

X-Twist Biocomposite Suture Anchor 5.5mm

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00816342025478
• NIH Device Record Key: bffe91da-4da4-4822-88e4-86c4c52f54bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Twist Biocomposite
• Version Model Number: XT45500
• 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: 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	00816342025478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232513

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: 2025-05-07
• Device Publish Date: 2025-04-29

On-Brand Devices [X-Twist Biocomposite]

• 00816342025515: X-Twist Biocomposite Suture Anchor 6.25mm
• 00816342025508: X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025492: X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025485: X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025478: X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025461: X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025454: X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025447: X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342022491: X-Twist Biocomposite Suture Anchor 4.75mm