Versa-Fx® 00-1193-095-20

GUDID 00889024036871

Zimmer, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00889024036871
• NIH Device Record Key: 276c5cd9-7764-43e8-a9a7-ab67219426a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versa-Fx®
• Version Model Number: 1193-95-20
• Catalog Number: 00-1193-095-20
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree
• Device Size Text, specify: 0
• Length: 331 Millimeter
• Angle: 95 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024036871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150818

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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: 2019-08-12
• Device Publish Date: 2015-09-17

On-Brand Devices [Versa-Fx®]

• 00889024037977: 1198-95-14
• 00889024037960: 1198-95-11
• 00889024037953: 1198-95-08
• 00889024037946: 1198-90-11
• 00889024037939: 1198-90-08
• 00889024037878: 1194-150-08
• 00889024037861: 1194-150-06
• 00889024037854: 1194-150-05
• 00889024037847: 1194-150-04
• 00889024037830: 1194-145-08
• 00889024037823: 1194-145-06
• 00889024037816: 1194-145-05
• 00889024037809: 1194-145-04
• 00889024037793: 1194-140-08
• 00889024037786: 1194-140-06
• 00889024037779: 1194-140-05
• 00889024037762: 1194-140-04
• 00889024037755: 1194-135-96
• 00889024037748: 1194-135-95
• 00889024037731: 1194-135-94
• 00889024037724: 1194-135-08
• 00889024037717: 1194-135-06
• 00889024037700: 1194-135-05
• 00889024037694: 1194-135-04
• 00889024037687: 1194-130-08
• 00889024037670: 1194-130-06
• 00889024037663: 1194-130-05
• 00889024037656: 1194-130-04
• 00889024037649: 1193-150-96
• 00889024037632: 1193-150-95
• 00889024037625: 1193-150-94
• 00889024037618: 1193-150-20
• 00889024037601: 1193-150-18
• 00889024037595: 1193-150-16
• 00889024037588: 1193-150-14
• 00889024037571: 1193-150-12
• 00889024037564: 1193-150-10
• 00889024037557: 1193-150-08
• 00889024037540: 1193-150-06
• 00889024037533: 1193-150-05
• 00889024037526: 1193-150-04
• 00889024037519: 1193-150-03
• 00889024037502: 1193-150-02
• 00889024037496: 1193-145-96
• 00889024037489: 1193-145-95
• 00889024037472: 1193-145-94
• 00889024037465: 1193-145-20
• 00889024037458: 1193-145-18
• 00889024037441: 1193-145-16
• 00889024037434: 1193-145-14