CORTICAL LOCKING SCREW 816145258

GUDID 00887868044007

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868044007
• NIH Device Record Key: e57a1285-08c2-4b69-a393-94ccb854b23f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORTICAL LOCKING SCREW
• Version Model Number: 8161-45-258
• Catalog Number: 816145258
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, 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: false
• 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)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868044007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072423

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

[00887868044007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [CORTICAL LOCKING SCREW]

• 00887868044021: 8161-45-265
• 00887868044014: 8161-45-260
• 00887868044007: 8161-45-258
• 00887868043994: 8161-45-256
• 00887868043987: 8161-45-254
• 00887868043970: 8161-45-252
• 00887868043963: 8161-45-250
• 00887868043956: 8161-45-248
• 00887868043949: 8161-45-246
• 00887868043932: 8161-45-244
• 00887868043925: 8161-45-242
• 00887868043918: 8161-45-240
• 00887868043901: 8161-45-238
• 00887868043895: 8161-45-236
• 00887868043888: 8161-45-234
• 00887868043871: 8161-45-232
• 00887868043864: 8161-45-230
• 00887868043857: 8161-45-228
• 00887868043840: 8161-45-226
• 00887868043833: 8161-45-224
• 00887868043826: 8161-45-222
• 00887868043819: 8161-45-220
• 00887868043802: 8161-45-218
• 00887868043796: 8161-45-216
• 00887868043789: 8161-45-214
• 00887868043772: 8161-45-212
• 00887868043765: 8161-45-210
• 00887868043758: 8161-45-208