RELJA Innovations Lapidus Screw Kit

GUDID 00860005968848

RELJA Innovations Lapidus Screw Kit

Relja Innovations LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00860005968848
• NIH Device Record Key: ad2ae07f-d114-480b-a4a5-a9d437596bdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELJA Innovations Lapidus Screw Kit
• Version Model Number: RI-LAP-LSK
• Company DUNS: 113596350
• Company Name: Relja Innovations LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005968848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211628

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2026-02-03
• Device Publish Date: 2026-01-26

Devices Manufactured by Relja Innovations LLC

• 00860005968848 - RELJA Innovations Lapidus Screw Kit: 2026-02-03RELJA Innovations Lapidus Screw Kit
• 00860005968848 - RELJA Innovations Lapidus Screw Kit: 2026-02-03 RELJA Innovations Lapidus Screw Kit
• 00860005968824 - RELJA Innovations Nitinol Staple Kit 15mmx12mm: 2025-09-29 RELJA Innovations Nitinol Staple Kit 15mmx12mm
• 00860005968831 - RELJA Innovations Nitinol Staple Kit 18x18: 2025-09-29 RELJA Innovations Nitinol Staple Kit 18x18
• 00860005968800 - MIS Precision Chevron Bunion System: 2024-02-19 The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subseq
• 00860005968817 - RELJA Reduction Clamp (Left and Right): 2024-01-11 The Relja Innovations Reduction Clamp is a manual surgical instrument intended to position and compress the metatarsal joints du