Slimplicity Anterior Cervical Plate System SDF4012-B

GUDID 00840019905046

4.0mm x 12mm SD Fixed Screw Blunt Tip

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840019905046
• NIH Device Record Key: 2a7d1dbc-5462-42ca-bfeb-b56ecb270ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slimplicity Anterior Cervical Plate System
• Version Model Number: SDF4012-B
• Catalog Number: SDF4012-B
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840019905046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060025

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

[00840019905046]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-19
• Device Publish Date: 2019-04-11

On-Brand Devices [Slimplicity Anterior Cervical Plate System]

• 00840019931038: Slimplicity Driver, AO Connect, 6.4"
• 00840019920926: Slimplicity ACP System Kit
• 00840019920902: Cervical Distraction Pin Caspar 18mm
• 00840019920896: Cervical Distraction Pin Caspar 16mm
• 00840019920889: Cervical Distraction Pin Caspar 14mm
• 00840019920872: Cervical Distraction Pin Caspar 12mm
• 00840019920865: Drill 3.0 x 16mm
• 00840019920858: Drill 3.0 x 14mm
• 00840019920841: Drill 3.0 x 12mm
• 00840019920827: Bone Awl
• 00840019920810: Variable Drill Guide
• 00840019920797: Cervical Plate Bender
• 00840019920773: ACP Lock/Unlock Tool
• 00840019920766: ACP Locking Tool
• 00840019931021: Slimplicity Driver, AO Connect, 5.5"
• 00840019920919: Slimplicity ACP Sterilization Case (Empty)
• 00840019920834: Fixation Pin (Bone Tack)
• 00840019920803: Fixed Drill Guide
• 00840019920780: 2.5mm Shaft Tapered Hex
• 00815362021439: 18mm Drill
• 00815362021422: 16mm Drill
• 00815362021415: 14mm Drill
• 00815362021408: 12mm Drill
• 00815362021392: Bone Awl
• 00815362021385: Bone Tap
• 00815362021378: Plate Bender
• 00815362021361: Lock/Unlock Tool
• 00815362021354: 4.5 x 18mm Variable Screw
• 00815362021347: 4.5 x 16mm Variable Screw
• 00815362021330: 4.5 x 14mm Variable Screw
• 00815362021323: 4.5 x 12mm Variable Screw
• 00815362021316: 4.5 x 18mm Fixed Screw
• 00815362021309: 4.5 x 16mm Fixed Screw
• 00815362021293: 4.5 x 14mm Fixed Screw
• 00815362021286: 4.5 x 12mm Fixed Screw
• 00815362021279: 2 Level 46mm Plate
• 00815362021262: 2 Level 44mm Plate
• 00815362021255: 2 Level 42mm Plate
• 00815362021248: 2 Level 40mm Plate
• 00815362021231: 2 Level 38mm Plate
• 00815362021224: 2 Level 36mm Plate
• 00815362021217: 2 Level 34mm Plate
• 00815362021200: 2 Level 32mm Plate
• 00815362021194: 2 Level 30mm Plate
• 00815362021187: 2 Level 28mm Plate
• 00815362021170: 2 Level 26mm Plate
• 00815362021163: 1 Level 28mm Plate
• 00815362021156: 1 Level 26mm Plate
• 00815362021149: 1 Level 24mm Plate
• 00815362021132: 1 Level 22mm Plate