11321H

GUDID M68511321H0

28 Knotless PEEK Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M68511321H0
• NIH Device Record Key: ff0e13ed-1a0d-419b-8306-dd64596dc8f4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 11321H
• Catalog Number: 11321H
• 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

Device Dimensions

• Outer Diameter: 2.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68511321H0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193295

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: 2020-03-05
• Device Publish Date: 2020-02-26

Devices Manufactured by PARCUS MEDICAL LLC

• 00816342023573 - Parcus Instrumentation: 2023-08-07 10mm SLiK Fix Drill Bit
• 00816342023580 - Parcus Instrumentation: 2023-08-07 1.8mm Reusable Draw Tight Drill Bit with Stop
• 00816342023634 - Parcus Instrumentation: 2023-08-07 3.0mm x 100mm Reusable Drill Bit with Stop
• 00816342023658 - Parcus Instrumentation: 2023-08-07 28 Knotless Reusable Drill Bit
• 00816342023726 - Parcus Instrumentation: 2023-08-07 1.1mm x 400mm Nitinol Guide Wire
• 00816342023740 - Parcus Instrumentation: 2023-08-07 28 Knotless Reusable Drill Guide, Hip Length
• 00816342023795 - Knotless Push-In Suture Anchor: 2023-08-07 35 Knotless Push-In Suture Anchor with Driver
• 00816342023931 - Twist PEEK Suture Anchor: 2023-08-07 4.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)