RESTORIS XLVE 186336-66

GUDID 00848486008833

Acetabular Liner

MAKO SURGICAL CORP.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00848486008833
• NIH Device Record Key: 63a9dcc2-11bb-4c1a-9f0a-8fb0e09feca3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORIS XLVE
• Version Model Number: 186336-66
• Catalog Number: 186336-66
• Company DUNS: 175239677
• Company Name: MAKO SURGICAL CORP.
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00848486008833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112802

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

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: 2015-09-24

On-Brand Devices [RESTORIS XLVE]

• 00848486010164: Acetabular Liner, High Wall
• 00848486010157: Acetabular Liner, High Wall
• 00848486010140: Acetabular Liner, High Wall
• 00848486010133: Acetabular Liner, High Wall
• 00848486010126: Acetabular Liner Neutral
• 00848486010119: Acetabular Liner Neutral
• 00848486010102: Acetabular Liner Neutral
• 00848486010096: Acetabular Liner Neutral
• 00848486009250: Acetabular Liner, High Wall
• 00848486009243: Acetabular Liner, High Wall
• 00848486009236: Acetabular Liner, High Wall
• 00848486009229: Acetabular Liner, High Wall
• 00848486009212: Acetabular Liner, High Wall
• 00848486009205: Acetabular Liner, High Wall
• 00848486009199: Acetabular Liner, High Wall
• 00848486009182: Acetabular Liner, High Wall
• 00848486009175: Acetabular Liner, High Wall
• 00848486009168: Acetabular Liner, High Wall
• 00848486009151: Acetabular Liner, High Wall
• 00848486009144: Acetabular Liner, High Wall
• 00848486009137: Acetabular Liner, High Wall
• 00848486009120: Acetabular Liner, High Wall
• 00848486009113: Acetabular Liner, Elevated
• 00848486009106: Acetabular Liner, Elevated
• 00848486009090: Acetabular Liner, Elevated
• 00848486009083: Acetabular Liner, Elevated
• 00848486009076: Acetabular Liner, Elevated
• 00848486009069: Acetabular Liner, Elevated
• 00848486009052: Acetabular Liner, Elevated
• 00848486009045: Acetabular Liner, Elevated
• 00848486009038: Acetabular Liner, Elevated
• 00848486009021: Acetabular Liner, Elevated
• 00848486009014: Acetabular Liner, Elevated
• 00848486009007: Acetabular Liner, Elevated
• 00848486008994: Acetabular Liner, Elevated
• 00848486008987: Acetabular Liner
• 00848486008970: Acetabular Liner, High Wall
• 00848486008963: Acetabular Liner, High Wall
• 00848486008956: Acetabular Liner, High Wall
• 00848486008949: Acetabular Liner, High Wall
• 00848486008932: Acetabular Liner, High Wall
• 00848486008925: Acetabular Liner, High Wall
• 00848486008918: Acetabular Liner, High Wall
• 00848486008901: Acetabular Liner, High Wall
• 00848486008895: Acetabular Liner, High Wall
• 00848486008888: Acetabular Liner, High Wall
• 00848486008871: Acetabular Liner, High Wall
• 00848486008864: Acetabular Liner, High Wall
• 00848486008857: Acetabular Liner, High Wall
• 00848486008840: Acetabular Liner, High Wall