AUXILOCK PEEK OPTIMA Screw-In Suture Anchor

GUDID 08903993499856

AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White & White/Blue, with Needles: MO-6

Auxein Medical Private Limited

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 08903993499856
• NIH Device Record Key: ee3ea91f-8f02-4b3e-a81d-6df904503cdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUXILOCK PEEK OPTIMA Screw-In Suture Anchor
• Version Model Number: 6-016-01
• Company DUNS: 872194615
• Company Name: Auxein Medical Private Limited
• Device Count: 1
• DM Exempt: false
• 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: true
• 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

Customer Support Contacts

• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993499856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213110

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: 2026-01-28
• Device Publish Date: 2026-01-20

Devices Manufactured by Auxein Medical Private Limited

• 08903993499856 - AUXILOCK PEEK OPTIMA Screw-In Suture Anchor: 2026-01-28AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White & White/Blue, with Needles: MO-6
• 08903993499856 - AUXILOCK PEEK OPTIMA Screw-In Suture Anchor: 2026-01-28 AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White & White/Blue, with Needles: MO-6
• 08903993215548 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 10 Holes: 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
• 08903993215555 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 11 Holes: 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
• 08903993215562 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 12 Holes: 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
• 08903993215579 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 13 Holes: 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
• 08903993215586 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 14 Holes: 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
• 08903993215593 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 15 Holes: 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia
• 08903993215609 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 16 Holes: 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia