254502

GUDID 10886705012947

ABSOLUTE Absorbable Interference Screw 7 x 30mm

DEPUY MITEK, LLC

Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw

• Primary Device ID: 10886705012947
• NIH Device Record Key: 6a3a78f0-191d-4698-b77a-461a9c4717c7
• Commercial Distribution Discontinuation: 2021-01-28
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 254502
• Catalog Number: 254502
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705012947 [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

• 10886705000913 - NA: 2024-05-30 Rotator Cuff Anchor Threader Tab
• 10886705001064 - LUPINE ORTHOCORD: 2024-05-30 LUPINE Loop Plus Anchor w/ORTHOCORD Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Sut
• 10886705001071 - LUPINE ORTHOCORD: 2024-05-30 LUPINE Loop PLUS Dual Suture (DS) Anchor w/ORTHOCORD PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composi
• 10886705002412 - QUICKANCHOR PANACRYL: 2024-05-30 MINILOK QUICKANCHOR Plus (Number 2/0) Suture Poly (L-lactide) absorbable anchor, size 2/0 PANACRYL braided absorbable suture (3
• 10886705006991 - NA: 2024-05-30 PATHMAKER REPLACEMENT SCREW
• 20886705008206 - FASTIN ETHIBOND: 2024-05-30 FASTIN ANCHOR Size 2 (5 metric) green ETHIBOND braided polyester suture, 26 Inches (66cm), Anchor 4.0mm Diameter x 9.7mm long.
• 10886705008247 - FASTIN ETHIBOND: 2024-05-30 FASTIN RC Anchor with ETHIBOND w/Needles Titanium Anchor with two Number 2 ETHIBOND Braided Polyester Sutures, 36 Inches (91cm),
• 10886705008254 - FASTIN ETHIBOND: 2024-05-30 FASTIN RC Anchor with ETHIBOND Titanium Anchor with two Number 2 ETHIBOND Braided Polyester Sutures, 36 Inches (91cm), Green and