TACIT 222220

GUDID 20886705007681

TACIT ANCHOR With Double Ended Threader Tab 2.0mm

DEPUY MITEK, LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 20886705007681
• NIH Device Record Key: f3c5e2f4-b1a5-4e60-9455-fa8deba84aab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TACIT
• Version Model Number: 222220
• Catalog Number: 222220
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0
• Handling Environment Temperature: Between 77 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 0
• Handling Environment Temperature: Between 77 Degrees Celsius and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705007684 [Unit of Use]
GS1	20886705007681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945203

FDA Product Code

• JDR: STAPLE, 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: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-09-01

On-Brand Devices [TACIT]

• 20886705007681: TACIT ANCHOR With Double Ended Threader Tab 2.0mm
• 10886705006809: TACIT Inserter 2.0mm
• 10886705001767: TACIT Drill With Stop-Hand 1.7mm
• 10886705001385: TACIT Drill Drill Craniofacial 1.7mm