4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM 8013-0348

GUDID 08806373587320

4CIS® Pinehurst Anterior Cervical Plate 3Level 48mm

SOLCO BIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08806373587320
• NIH Device Record Key: 12783526-0d0d-4e5c-944b-e94178b2363e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM
• Version Model Number: 8013-0348
• Catalog Number: 8013-0348
• Company DUNS: 687844241
• Company Name: SOLCO BIOMEDICAL CO.,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: false
• 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	08806373587320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182489

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

[08806373587320]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2019-01-23

On-Brand Devices [4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM]

• 08806373588143: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 22mm
• 08806373588136: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 20mm
• 08806373588129: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 19mm
• 08806373588112: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 18mm
• 08806373588105: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 17mm
• 08806373588099: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 15mm
• 08806373588082: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 13mm
• 08806373588075: 4CIS® Pinehurst Variable Self Tapping Screw ø4.0 X 11mm
• 08806373588068: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 22mm
• 08806373588051: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 20mm
• 08806373588044: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 19mm
• 08806373588037: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 18mm
• 08806373588020: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 17mm
• 08806373588013: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 15mm
• 08806373588006: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 13mm
• 08806373587993: 4CIS® Pinehurst Variable Self Tapping Screw ø3.5 X 11mm
• 08806373587986: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 22mm
• 08806373587979: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 20mm
• 08806373587962: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 19mm
• 08806373587955: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 18mm
• 08806373587948: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 17mm
• 08806373587931: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 15mm
• 08806373587924: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 13mm
• 08806373587917: 4CIS® Pinehurst Variable Self Drilling Screw ø4.0 X 11mm
• 08806373587900: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 22mm
• 08806373587894: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 20mm
• 08806373587887: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 19mm
• 08806373587870: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 18mm
• 08806373587863: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 17mm
• 08806373587856: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 15mm
• 08806373587849: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 13mm
• 08806373587832: 4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 11mm
• 08806373587825: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 22mm
• 08806373587818: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 20mm
• 08806373587801: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 19mm
• 08806373587795: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 18mm
• 08806373587788: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 17mm
• 08806373587771: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 15mm
• 08806373587764: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 13mm
• 08806373587757: 4CIS® Pinehurst Fixed Self Tapping Screw ø4.0 X 11mm
• 08806373587740: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 22mm
• 08806373587733: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 20mm
• 08806373587726: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 19mm
• 08806373587719: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 18mm
• 08806373587702: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 17mm
• 08806373587696: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 15mm
• 08806373587689: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 13mm
• 08806373587672: 4CIS® Pinehurst Fixed Self Tapping Screw ø3.5 X 11mm
• 08806373587665: 4CIS® Pinehurst Fixed Self Drilling Screw ø4.0 X 22mm
• 08806373587658: 4CIS® Pinehurst Fixed Self Drilling Screw ø4.0 X 19mm