My Spine Pedicle Screw Placement Guides

GUDID 07630030856082

MySpine vertebra T04 STERILE

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030856082
• NIH Device Record Key: 468e19e5-a009-49c1-b7f1-a7b3b55ee190
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Spine Pedicle Screw Placement Guides
• Version Model Number: 7.0004S
• 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	07630030856082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132788

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: 2014-11-18

On-Brand Devices [My Spine Pedicle Screw Placement Guides]

• 07630030856761: MySpine drill guide L05 STERILE
• 07630030856754: MySpine drill guide L05
• 07630030856747: MySpine drill guide L04 STERILE
• 07630030856730: MySpine drill guide L04
• 07630030856723: MySpine drill guide L03 STERILE
• 07630030856716: MySpine drill guide L03
• 07630030856709: MySpine drill guide L02 STERILE
• 07630030856693: MySpine drill guide L02
• 07630030856686: MySpine drill guide L01 STERILE
• 07630030856679: MySpine drill guide L01
• 07630030856662: MySpine drill guide T12 STERILE
• 07630030856655: MySpine drill guide T12
• 07630030856648: MySpine drill guide T11 STERILE
• 07630030856631: MySpine drill guide T11
• 07630030856624: MySpine drill guide T10 STERILE
• 07630030856617: MySpine drill guide T10
• 07630030856600: MySpine drill guide T09 STERILE
• 07630030856594: MySpine drill guide T09
• 07630030856587: MySpine drill guide T08 STERILE
• 07630030856570: MySpine drill guide T08
• 07630030856563: MySpine drill guide T07 STERILE
• 07630030856556: MySpine drill guide T07
• 07630030856549: MySpine drill guide T06 STERILE
• 07630030856532: MySpine drill guide T06
• 07630030856525: MySpine drill guide T05 STERILE
• 07630030856518: MySpine drill guide T05
• 07630030856501: MySpine drill guide T04 STERILE
• 07630030856495: MySpine drill guide T04
• 07630030856488: MySpine drill guide T03 STERILE
• 07630030856471: MySpine drill guide T03
• 07630030856464: MySpine drill guide T02 STERILE
• 07630030856457: MySpine drill guide T02
• 07630030856440: MySpine drill guide T01 STERILE
• 07630030856433: MySpine drill guide T01
• 07630030856426: Screwdriver sleeve STERILE
• 07630030856419: Screwdriver sleeve
• 07630030856402: Lumbar probe sleeve STERILE
• 07630030856396: Lumbar probe sleeve
• 07630030856389: Thoracic probe sleeve STERILE
• 07630030856372: Thoracic probe sleeve
• 07630030856365: Awl sleeve STERILE
• 07630030856358: Awl sleeve
• 07630030856341: MySpine vertebra L05 STERILE
• 07630030856334: MySpine vertebra L05
• 07630030856327: MySpine vertebra L04 STERILE
• 07630030856310: MySpine vertebra L04
• 07630030856303: MySpine vertebra L03 STERILE
• 07630030856297: MySpine vertebra L03
• 07630030856280: MySpine vertebra L02 STERILE
• 07630030856273: MySpine vertebra L02