254501

GUDID 10886705012930

ABSOLUTE Absorbable Interference Screw 7 x 23mm

DEPUY MITEK, LLC

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 10886705012930
• NIH Device Record Key: 5ad3105f-63b9-45ba-bf18-254ea27d3906
• Commercial Distribution Discontinuation: 2021-01-28
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 254501
• Catalog Number: 254501
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, 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: 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705012930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990454

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-07
• Device Publish Date: 2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

• 10886705001316 - RIGIDFIX BIOCRYL: 2025-03-04 RIGIDFIX BIOCRYL TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and
• 10886705000807 - PANALOK ETHIBOND: 2025-02-17 PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with C
• 10886705000920 - RIGIDFIX: 2025-02-17 RIGIDFIX TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm Absorbable Poly Lactic Acid (PLA), (2) each Sleeve Assembl
• 10886705001156 - PANALOK PANACRYL: 2025-02-17 PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) PANACRYL absorbable braided suture, 36 Inches (91cm), double-armed with CP-2 n
• 10886705001323 - VERSALOK ORTHOCORD: 2025-02-17 VERSALOK PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches
• 10886705001941 - PANALOK QUICKANCHOR ETHIBOND: 2025-02-17 PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inc
• 10886705001965 - PANALOK QUICKANCHOR ETHIBOND: 2025-02-17 PANALOK RC QUICKANCHOR PLUS (DS) Dual Suture (DS) Poly (L-Lactide) absorbable anchor Size 2 (5 metric) Green and White ETHIBOND
• 10886705002009 - PANALOK QUICKANCHOR ORTHOCORD: 2025-02-17 PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Absorbable Anchor Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (