My Spine Low Profile Placement Guides

GUDID 07630030877575

MySpine LP vertebra T08 STERILE

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030877575
• NIH Device Record Key: 0a219626-051a-4e9a-b0b8-a4af6e13c3c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Spine Low Profile Placement Guides
• Version Model Number: 7.0408S
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630030877575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153273

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-08-31

On-Brand Devices [My Spine Low Profile Placement Guides]

• 07630030878091: MySpine LP guide L05 STERILE
• 07630030878084: MySpine LP guide L05
• 07630030878077: MySpine LP guide L04 STERILE
• 07630030878060: MySpine LP guide L04
• 07630030878053: MySpine LP guide L03 STERILE
• 07630030878046: MySpine LP guide L03
• 07630030878039: MySpine LP guide L02 STERILE
• 07630030878022: MySpine LP guide L02
• 07630030878015: MySpine LP guide L01 STERILE
• 07630030878008: MySpine LP guide L01
• 07630030877995: MySpine LP guide T12 STERILE
• 07630030877988: MySpine LP guide T12
• 07630030877971: MySpine LP guide T11 STERILE
• 07630030877964: MySpine LP guide T11
• 07630030877957: MySpine LP guide T10 STERILE
• 07630030877940: MySpine LP guide T10
• 07630030877933: MySpine LP guide T09 STERILE
• 07630030877926: MySpine LP guide T09
• 07630030877919: MySpine LP guide T08 STERILE
• 07630030877902: MySpine LP guide T08
• 07630030877896: MySpine LP guide T07 STERILE
• 07630030877889: MySpine LP guide T07
• 07630030877872: MySpine LP guide T06 STERILE
• 07630030877865: MySpine LP guide T06
• 07630030877858: MySpine LP guide T05 STERILE
• 07630030877841: MySpine LP guide T05
• 07630030877834: MySpine LP guide T04 STERILE
• 07630030877827: MySpine LP guide T04
• 07630030877810: MySpine LP guide T03 STERILE
• 07630030877803: MySpine LP guide T03
• 07630030877797: MySpine LP guide T02 STERILE
• 07630030877780: MySpine LP guide T02
• 07630030877773: MySpine LP guide T01 STERILE
• 07630030877766: MySpine LP guide T01
• 07630030877759: MySpine LP vertebra L05 STERILE
• 07630030877742: MySpine LP vertebra L05
• 07630030877735: MySpine LP vertebra L04 STERILE
• 07630030877728: MySpine LP vertebra L04
• 07630030877711: MySpine LP vertebra L03 STERILE
• 07630030877704: MySpine LP vertebra L03
• 07630030877698: MySpine LP vertebra L02 STERILE
• 07630030877681: MySpine LP vertebra L02
• 07630030877674: MySpine LP vertebra L01 STERILE
• 07630030877667: MySpine LP vertebra L01
• 07630030877650: MySpine LP vertebra T12 STERILE
• 07630030877643: MySpine LP vertebra T12
• 07630030877636: MySpine LP vertebra T11 STERILE
• 07630030877629: MySpine LP vertebra T11
• 07630030877612: MySpine LP vertebra T10 STERILE
• 07630030877605: MySpine LP vertebra T10