Pinehurst Anterior Cervical Plate System

GUDID 09348215030759

SIGNATURE ORTHOPAEDICS PTY LTD

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 09348215030759
• NIH Device Record Key: e158c987-febb-46d0-a83c-e10b62bf1e11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pinehurst Anterior Cervical Plate System
• Version Model Number: PS1-16-3045
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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: true
• 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	09348215030759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181190

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2019-02-19

On-Brand Devices [Pinehurst Anterior Cervical Plate System]

• 09348215030896: PS1-16-4088
• 09348215030889: PS1-16-4084
• 09348215030872: PS1-16-4080
• 09348215030865: PS1-16-4076
• 09348215030858: PS1-16-4072
• 09348215030841: PS1-16-4068
• 09348215030834: PS1-16-4064
• 09348215030827: PS1-16-3066
• 09348215030810: PS1-16-3063
• 09348215030803: PS1-16-3060
• 09348215030797: PS1-16-3057
• 09348215030780: PS1-16-3054
• 09348215030773: PS1-16-3051
• 09348215030766: PS1-16-3048
• 09348215030759: PS1-16-3045
• 09348215030742: PS1-16-3042
• 09348215030735: PS1-16-2044
• 09348215030728: PS1-16-2042
• 09348215030711: PS1-16-2040
• 09348215030704: PS1-16-2038
• 09348215030698: PS1-16-2036
• 09348215030681: PS1-16-2034
• 09348215030674: PS1-16-2032
• 09348215030667: PS1-16-2030
• 09348215030650: PS1-16-1030
• 09348215030643: PS1-16-1028
• 09348215030636: PS1-16-1026
• 09348215030629: PS1-16-1024
• 09348215030612: PS1-16-1022
• 09348215030605: PS1-16-1020
• 09348215030599: PS1-16-1018
• 09348215030582: PS1-16-1016
• 09348215030575: PS1-16-1014
• 09348215030568: PS1-16-1012