Twist PEEK Suture Anchor

GUDID 00816342023931

4.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)

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: 00816342023931
• NIH Device Record Key: 5d493ce0-f0b3-4c90-a712-43ecb2e9e5d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist PEEK Suture Anchor
• Version Model Number: 11003
• 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	00816342023931 [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: 2023-08-07
• Device Publish Date: 2023-07-29

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• 00816342025188: Twist 4.5mm PEEK SST Suture Anchor
• 00816342024365: Twist 5.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
• 00816342024358: Twist 5.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
• 00816342024341: Twist 4.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
• 00816342024334: Twist 4.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
• 00816342024174: 6.5 x 12.6mm, Twist, screw-in, suture anchor, w/2, 1.6mm suture tapes (wht/blu & wht/blk), PEEK
• 00816342023948: 5.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)
• 00816342023931: 4.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)