Twist 10521

GUDID M685105211

Twist 4.5mm PEEK Suture Anchor with Needles

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M685105211
• NIH Device Record Key: 28b577d9-7f93-4f69-b301-c93f76130f78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist
• Version Model Number: 10521
• Catalog Number: 10521
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 6
• 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: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M685105210 [Unit of Use]
HIBCC	M685105211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120942

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: 2019-07-03
• Device Publish Date: 2019-06-25

On-Brand Devices [Twist]

• M685105230: Twist 6.5mm PEEK Suture Anchor with Needles
• M685105220: Twist 5.5mm PEEK Suture Anchor with Needles
• M685105211: Twist 4.5mm PEEK Suture Anchor with Needles
• M685105210: Twist 4.5mm PEEK Suture Anchor with Needles
• M68510518T0: Twist 6.5mm PEEK Suture Anchor
• M68510517T1: Twist 5.5mm PEEK Suture Anchor
• M68510517T0: Twist 5.5mm PEEK Suture Anchor
• M68510511T0: Twist 4.5mm PEEK Suture Anchor
• M685112860: Twist 5.5mm PEEK Suture Anchor
• M685112850: Twist 4.5mm PEEK Suture Anchor
• M685112840: Twist 5.5mm PEEK Suture Anchor
• M685112830: Twist 4.5mm PEEK Suture Anchor
• M685113600: 6.5mm Twist AP SST Suture Anchor
• M685113590: 6.5mm Twist AP SST Suture Anchor
• M685113580: 5.5mm Twist AP SST Suture Anchor
• M685113570: 5.5mm Twist AP SST Suture Anchor
• M685111270: 6.5mm Twist AP Suture Anchor
• M685111260: 5.5mm Twist AP Suture Anchor
• M685111250: 4.5mm Twist AP Suture Anchor
• M68510798T0: 6.5mm Twist AP Suture Anchor
• M68510797T0: 5.5mm Twist AP Suture Anchor
• M68510796T0: 4.5mm Twist AP Suture Anchor
• 00816342024945: 5.5mm Twist Biocomposite Suture Anchor
• 00816342023825: Twist 4.5mm PEEK Suture Anchor with Needles
• 00816342024921: 6.5mm Twist Biocomposite SST Suture Anchor
• 00816342025287: 5.5mm Twist Biocomposite Suture Anchor
• 00816342024938: 5.5mm Twist Biocomposite Suture Anchor
• 00816342024914: 6.5mm Twist Biocomposite SST Suture Anchor
• 00816342024907: 5.5mm Twist Biocomposite SST Suture Anchor
• 00816342024891: 5.5mm Twist Biocomposite SST Suture Anchor
• 00816342024884: 6.5mm Twist Biocomposite Suture Anchor
• 00816342024877: 5.5mm Twist Biocomposite Suture Anchor
• 00816342024860: 4.5mm Twist Biocomposite Suture Anchor
• 00816342024853: 6.5mm Twist Biocomposite Suture Anchor
• 00816342024846: 5.5mm Twist Biocomposite Suture Anchor
• 00816342024839: 4.5mm Twist Biocomposite Suture Anchor
• 00816342022484: Twist 5.5mm PEEK Suture Anchor
• 00816342022354: Twist 6.5mm PEEK Suture Anchor
• 00816342022347: Twist 5.5mm PEEK Suture Anchor
• 00816342022330: Twist 6.5mm PEEK Suture Anchor
• 00816342022323: Twist 4.5mm PEEK Suture Anchor
• 00816342021494: Twist 6.5mm PEEK Suture Anchor with Needles
• 00816342021487: Twist 5.5mm PEEK Suture Anchor with Needles