Slik Fix Screw

GUDID 00816342023443

8.0 x 15 SLiK Fix PEEK Screw

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342023443
• NIH Device Record Key: 495e770d-1d87-4c8e-b872-435b766e9b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slik Fix Screw
• Version Model Number: 10953
• 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	00816342023443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170877

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 Fix Screw]

• 00816342023481: 7.0 x 15 SLiK Fix PEEK CF Screw
• 00816342023474: 8.0 x 15 SLiK Fix PEEK CF Screw
• 00816342023467: 9.0 x 15 SLiK Fix PEEK CF Screw
• 00816342023450: 9.0 x 15 SLiK Fix PEEK Screw
• 00816342023443: 8.0 x 15 SLiK Fix PEEK Screw
• 00816342023436: 7.0 x 15 SLiK Fix PEEK Screw