Slik Anchor

GUDID 00816342023412

5.5 x 15 SLiK PEEK CF Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342023412
• NIH Device Record Key: 4f588860-6694-4f24-9380-f460dd71749c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slik Anchor
• Version Model Number: 10957
• 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	00816342023412 [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: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [Slik Anchor]

• 00816342023399: 6.25 x 15 Slik PEEK Anchor
• 00816342023429: 4.75 x 15 SLiK PEEK CF Anchor
• 00816342023412: 5.5 x 15 SLiK PEEK CF Anchor
• 00816342023405: 6.25 x 15 SLiK PEEK CF Anchor
• 00816342023382: 5.5 x 15 SLiK PEEK Anchor
• 00816342023375: 4.75 x 15 SLiK PEEK Anchor