ORTHOPEDIC SALVAGE SYSTEM (OSS™) 161012

GUDID 05019279057580

Biomet Orthopedics, LLC

Coated knee femur prosthesis

• Primary Device ID: 05019279057580
• NIH Device Record Key: ffadc324-ba0b-4b88-89c5-9d5995e0e2b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOPEDIC SALVAGE SYSTEM (OSS™)
• Version Model Number: 161012
• Catalog Number: 161012
• 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: 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)348-9500
• Email: customerservice@zimmerbiomet.c

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05019279057580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021260

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-25

On-Brand Devices [ORTHOPEDIC SALVAGE SYSTEM (OSS™)]

• 00880304840416: CP113462
• 00880304806719: 110030649
• 00880304806702: 110030648
• 00880304806696: 110030647
• 00880304806689: 110030646
• 00880304806672: 110030554
• 00880304806665: 110030553
• 00880304806290: 110030551
• 00880304806283: 110030550
• 00880304806276: 110030549
• 00880304806269: 110030548
• 00880304806252: 110030547
• 00880304806245: 110030546
• 00880304806238: 110030545
• 00880304806221: 110030544
• 00880304806214: 110030543
• 00880304806207: 110030542
• 00880304806191: 110030541
• 00880304806184: 110030540
• 00880304806177: 110030539
• 00880304806160: 110030538
• 00880304806153: 110030537
• 00880304805309: 110030079
• 00880304805293: 110030078
• 00880304805286: 110030077
• 00880304805279: 110030075
• 00880304805255: 110030072
• 00880304805248: 110030070
• 00880304805231: 110030076
• 00880304805224: 110030074
• 00880304805217: 110030069
• 00880304805200: 110030068
• 00880304805194: 110030067
• 00880304805187: 110030066
• 00880304805170: 110027896
• 00880304737457: 110029078
• 00880304737440: 110029077
• 00880304250765: 161011
• 05019279057580: 161012
• 00887868343940: 161034
• 00887868343933: 150478
• 00887868224164: 151823
• 00880304805262: 110030073