C3® ACPS

GUDID 03663136002163

66 mm plate with SLS

SPINEVISION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 03663136002163
• NIH Device Record Key: aceca43f-2faa-4af2-98c4-11c19d993589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C3® ACPS
• Version Model Number: C1-P3 0660
• Company DUNS: 390377518
• Company Name: SPINEVISION
• 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: 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 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	03663136002163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012881

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

[03663136002163]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-01-08
• Device Publish Date: 2015-10-15

On-Brand Devices [C3® ACPS]

• 03663136002415: 4.0 mm x 20 mm variable angle screw
• 03663136001906: 31.5 mm plate with SLS
• 03663136001746: 4.0 mm x 12 mm dual purpose screw
• 03663136019642: Spring locking system for 78 plate
• 03663136019444: Spring locking system for 29 plate
• 03663136002279: 93 mm plate with SLS
• 03663136002224: 73 mm plate with SLS
• 03663136002040: 49 mm plate with SLS
• 03663136001975: 39mm 1 LEVEL PLATE WITH SLS
• 03663136019758: Spring locking system for 109 plate
• 03663136019741: Spring locking system for 105 plate
• 03663136019734: Spring locking system for 101 plate
• 03663136019727: Spring locking system for 97 plate
• 03663136019710: Spring locking system for 93 plate
• 03663136019703: Spring locking system for 89 plate
• 03663136019697: Spring locking system for 85 plate
• 03663136019680: Spring locking system for 81 plate
• 03663136019673: Spring locking system for 77 plate
• 03663136019666: Spring locking system for 73 plate
• 03663136019659: Spring locking system for 69 plate
• 03663136019635: Spring locking system for 75 plate
• 03663136019628: Spring locking system for 72 plate
• 03663136019611: Spring locking system for 69 plate
• 03663136019604: Spring locking system for 66 plate
• 03663136019598: Spring locking system for 63 plate
• 03663136019581: Spring locking system for 60 plate
• 03663136019567: Spring locking system for 54 plate
• 03663136019550: Spring locking system for 56,5 plate
• 03663136019543: Spring locking system for 54 plate
• 03663136019536: Spring locking system for 51,5 plate
• 03663136019529: Spring locking system for 49 plate
• 03663136019512: Spring locking system for 46,5 plate
• 03663136019505: Spring locking system for 44 plate
• 03663136019499: Spring locking system for 41,5 plate
• 03663136019475: Spring locking system for 36,5 plate
• 03663136019468: Spring locking system for 34 plate
• 03663136019451: Spring locking system for 31,5 plate
• 03663136019437: Spring locking system for 26,5 plate
• 03663136019420: Spring locking system for 24 plate
• 03663136019413: Spring locking system for 21,5 plate
• 03663136002453: 4.0 mm x 16 mm variable angle self drilling screw
• 03663136002446: 4.0 mm x 14 mm variable angle self drilling screw
• 03663136002439: 4.0 mm x 12 mm variable angle self drilling screw
• 03663136002422: SLS screws
• 03663136002408: 4.0 mm x 19 mm variable angle screw
• 03663136002392: 4.0 mm x 18 mm variable angle screw
• 03663136002385: 4.0 mm x 16 mm variable angle screw
• 03663136002378: 4.0 mm x 14 mm variable angle screw
• 03663136002361: 4.0 mm x 12 mm variable angle screw
• 03663136002347: 4.5 mm x 16 mm variable angle screw