Twist Knotless

GUDID 00816342024037

4.75 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342024037
• NIH Device Record Key: 440f6772-12e4-408d-afde-43d55200a6a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist Knotless
• Version Model Number: 11259
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00816342024037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170327

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: 2023-08-07
• Device Publish Date: 2023-07-29

On-Brand Devices [Twist Knotless]

• M685111670: 6.25 x 15 Twist Knotless PEEK Suture Anchor
• M685111660: 5.5 x 15 Twist Knotless PEEK Suture Anchor
• M685111650: 4.75 x 15 Twist Knotless PEEK Suture Anchor
• 00816342024013: 5.5 x 15 Twist Knotless PEEK Suture Anchor
• 00816342024051: 6.25 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK
• 00816342024044: 5.5 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK
• 00816342024037: 4.75 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK
• 00816342024020: 6.25 x 15mm, Twist, knotless, screw-in, suture anchor, w/suture threader, PEEK
• 00816342024006: 4.75 x 15mm, Twist, knotless, screw-in, suture anchor, w/suture threader, PEEK