X-Twist PEEK XT25502

GUDID 00816342025362

X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, blue

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342025362
• NIH Device Record Key: 4d436f62-a431-4a94-a44a-8b59e21a7ebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Twist PEEK
• Version Model Number: XT25502
• Catalog Number: XT25502
• 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

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342025362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221135

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: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [X-Twist PEEK]

• 00816342025386: X-Twist PEEK 6.25mm suture anchor, 1 x No 2 suture
• 00816342025379: X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, black
• 00816342025362: X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, blue
• 00816342025355: X-Twist PEEK 5.5mm suture anchor, 1 x No 2 suture
• 00816342025348: X-Twist PEEK 4.75mm suture anchor, 2 x 1.6mm tapes, black
• 00816342025331: X-Twist PEEK 4.75mm suture anchor, 2 x 1.6mm tapes, blue
• 00816342025324: X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes
• 00816342025317: X-Twist PEEK 4.75mm suture anchor, 1 x No 2 suture
• 00816342025300: X-Twist PEEK suture anchor, 1 x 1.6mm tape