RESTORIS PST 186002-64

GUDID 00848486008420

Acetabular Shell, Cluster Hole

MAKO SURGICAL CORP.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 00848486008420
• NIH Device Record Key: 2ff542aa-fa9e-4bd8-8528-cd39ea1c6222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORIS PST
• Version Model Number: 186002-64
• Catalog Number: 186002-64
• 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 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	00848486008420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112802

FDA Product Code

• OQH: Hip, semi-constrained, cemented, metal/polymer + additive, cemented

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 PST]

• 00848486016265: Porous Tibial Baseplate
• 00848486016258: Porous Tibial Baseplate
• 00848486016241: Porous Tibial Baseplate
• 00848486016234: Porous Tibial Baseplate
• 00848486016227: Porous Tibial Baseplate
• 00848486016210: Porous Tibial Baseplate
• 00848486016203: Porous Tibial Baseplate
• 00848486016197: Porous Tibial Baseplate
• 00848486016180: Porous Tibial Baseplate
• 00848486016173: Porous Tibial Baseplate
• 00848486016166: Porous Tibial Baseplate
• 00848486016159: Porous Tibial Baseplate
• 00848486016142: Porous Tibial Baseplate
• 00848486016135: Porous Tibial Baseplate
• 00848486016128: Porous Tibial Baseplate
• 00848486016111: Porous Tibial Baseplate
• 00848486008444: Acetabular Shell, Cluster Hole
• 00848486008437: Acetabular Shell, Cluster Hole
• 00848486008420: Acetabular Shell, Cluster Hole
• 00848486008413: Acetabular Shell, Cluster Hole
• 00848486008406: Acetabular Shell, Cluster Hole
• 00848486008390: Acetabular Shell, Cluster Hole
• 00848486008383: Acetabular Shell, Cluster Hole
• 00848486008376: Acetabular Shell, Cluster Hole
• 00848486008369: Acetabular Shell, Cluster Hole
• 00848486008352: Acetabular Shell, Cluster Hole
• 00848486008345: Acetabular Shell, Cluster Hole
• 00848486008338: Acetabular Shell, Cluster Hole
• 00848486008321: Acetabular Shell, Cluster Hole