NexGen SSI004649

GUDID 00889024518322

Zimmer, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00889024518322
• NIH Device Record Key: ca219b85-2439-48e6-ad91-618e921e6bad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen
• Version Model Number: SSI004649
• Catalog Number: SSI004649
• 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: false
• Lot Batch: false
• Serial Number: true
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024518322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152494

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

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

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

[00889024518322]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-08-23

On-Brand Devices [NexGen]

• 00889024561939: SSI004800
• 00889024561922: SSI004799
• 00889024561915: SSI004798
• 00889024561908: SSI004797
• 00887868259098: SSI004713
• 00887868259081: SSI004712
• 00889024569461: 82-0156-400-70
• 00889024569454: 82-0156-400-60
• 00889024569362: 82-0156-234-00
• 00889024569355: 82-0156-633-01
• 00889024568679: 82-0152-974-19
• 00889024568662: 82-0152-974-18
• 00889024568655: 82-0152-974-17
• 00889024568648: 82-0152-974-16
• 00889024568631: 82-0152-974-15
• 00889024568624: 82-0152-974-04
• 00889024568617: 82-0152-974-03
• 00889024568600: 82-0152-974-02
• 00889024568594: 82-0152-974-01
• 00889024568587: 82-0152-974-00
• 00889024564268: SSI004978
• 00889024564206: SSI004972
• 00889024563742: SSI004921
• 00889024563735: SSI004920
• 00889024563728: 82-0156-716-18
• 00889024563711: 82-0156-716-17
• 00889024563704: 82-0156-716-16
• 00889024563698: 82-0156-716-15
• 00889024563681: 82-0156-716-14
• 00889024563674: 82-0156-716-13
• 00889024563667: 82-0156-716-19
• 00889024563650: SSI004919
• 00889024563032: 82-0156-809-00
• 00889024550292: 82-0160-117-41
• 00889024550285: 82-0160-117-38
• 00889024550278: 82-0160-117-35
• 00889024550261: 82-0160-117-32
• 00889024550254: 82-0160-117-29
• 00889024520905: 82-0152-305-25
• 00889024518414: SSI004658
• 00889024518407: SSI004657
• 00889024518391: SSI004656
• 00889024518384: SSI004655
• 00889024518377: SSI004654
• 00889024518360: SSI004653
• 00889024518353: SSI004652
• 00889024518346: SSI004651
• 00889024518339: SSI004650
• 00889024518322: SSI004649
• 00889024518315: SSI004648