Spline Implant System

GUDID 00889024011830

ZIMMER DENTAL INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00889024011830
• NIH Device Record Key: f5f82cb3-b454-43d1-8d24-9ebead00f5e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spline Implant System
• Version Model Number: 1522
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL INC.
• Device Count: 1
• DM Exempt: true
• 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)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com

Device Dimensions

• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024011830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944327

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

[00889024011830]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-23

On-Brand Devices [Spline Implant System]

• 00889024013353: 2178
• 00889024013346: 2177
• 00889024013322: 2174
• 00889024012820: 1833
• 00889024012752: 1826
• 00889024012554: 1736
• 00889024012547: 1735
• 00889024012530: 1734
• 00889024012523: 1733
• 00889024012516: 1732
• 00889024012509: 1731
• 00889024012240: 1643
• 00889024012233: 1642
• 00889024012226: 1641
• 00889024012219: 1640
• 00889024012202: 1639
• 00889024012196: 1638
• 00889024012189: 1637
• 00889024012172: 1636
• 00889024012141: 1621
• 00889024012103: 1612
• 00889024012097: 1609
• 00889024011991: 1576
• 00889024011984: 1575
• 00889024011977: 1574
• 00889024011960: 1573
• 00889024011953: 1572
• 00889024011946: 1565
• 00889024011939: 1564
• 00889024011922: 1563
• 00889024011915: 1562
• 00889024011908: 1561
• 00889024011892: 1541
• 00889024011885: 1537
• 00889024011878: 1528
• 00889024011861: 1526
• 00889024011854: 1525
• 00889024011847: 1524
• 00889024011830: 1522
• 00889024011823: 1521
• 00889024011816: 1520
• 00889024011809: 1519
• 00889024011793: 1518
• 00889024011786: 1510
• 00889024011779: 1509
• 00889024011762: 1508
• 00889024011755: 1507
• 00889024011748: 1506
• 00889024011731: 1505
• 00889024011687: 1500