Slimplicity Plus Anterior Cervical Plating System 66-SV-4018-B

GUDID 00840019915878

Variable Blunt Screws 4mm x 18mm

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840019915878
• NIH Device Record Key: 810ebe0a-3155-4436-9787-e70a580e1d30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slimplicity Plus Anterior Cervical Plating System
• Version Model Number: 66-SV-4018-B
• Catalog Number: 66-SV-4018-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	00840019915878 [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

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

[00840019915878]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-03-27

On-Brand Devices [Slimplicity Plus Anterior Cervical Plating System]

• 00840019931007: Plate Bender
• 00840019921039: Slimplicity® Plus Self Drilling Screw Caddy (Empty)
• 00840019921022: Slimplicity® Self Drilling Screw Caddy (Empty)
• 00840019921015: Slimplicity® Plus 3 & 4 Level Plate Caddy (Empty)
• 00840019920988: Slimplicity® Plus Sterilization Case (Empty)
• 00840019920971: Temporary Fixation Pin
• 00840019920964: Drill - 16mm
• 00840019920957: Drill - 14mm
• 00840019920940: Drill - 12mm
• 00840019920933: Drill - 10mm
• 00840019916332: Slimplicity Plus ACP - 4 level, 81mm
• 00840019916325: Slimplicity Plus ACP - 4 level, 77mm
• 00840019916318: Slimplicity Plus ACP - 4 level, 73mm
• 00840019916301: Slimplicity Plus ACP - 4 level, 69mm
• 00840019916288: Slimplicity Plus ACP - 4 level, 61mm
• 00840019916271: Slimplicity Plus ACP - 4 level, 57mm
• 00840019916264: Slimplicity Plus ACP - 3 level, 67mm
• 00840019916257: Slimplicity Plus ACP - 3 level, 64mm
• 00840019916233: Slimplicity Plus ACP - 3 level, 58mm
• 00840019916226: Slimplicity Plus ACP - 3 level, 55mm
• 00840019916219: Slimplicity Plus ACP - 3 level, 52mm
• 00840019916202: Slimplicity Plus ACP - 3 level, 49mm
• 00840019916196: Slimplicity Plus ACP - 3 level, 46mm
• 00840019916189: Slimplicity Plus ACP - 3 level, 43mm
• 00840019916172: Slimplicity Plus ACP - 2 level, 47mm
• 00840019916165: Slimplicity Plus ACP - 2 level, 44mm
• 00840019916141: Slimplicity Plus ACP - 2 level, 38mm
• 00840019916134: Slimplicity Plus ACP - 2 level, 35mm
• 00840019916127: Slimplicity Plus ACP - 2 level, 32mm
• 00840019916110: Slimplicity Plus ACP - 2 level, 29mm
• 00840019916103: Slimplicity Plus ACP - 2 level, 27mm
• 00840019916097: Slimplicity Plus ACP - 2 level, 25mm
• 00840019916080: Slimplicity Plus ACP - 1 level, 26mm
• 00840019916073: Slimplicity Plus ACP - 1 level, 24mm
• 00840019916059: Slimplicity Plus ACP - 1 level, 20mm
• 00840019916042: Slimplicity Plus ACP - 1 level, 18mm
• 00840019916035: Slimplicity Plus ACP - 1 level, 16mm
• 00840019916028: Slimplicity Plus ACP - 1 level, 14mm
• 00840019916011: Slimplicity Plus ACP - 1 level, 12mm
• 00840019916004: Slimplicity Plus ACP - 1 level, 10mm
• 00840019915991: Variable Blunt Screws 4.5mm x 20mm
• 00840019915977: Variable Blunt Screws 4.5mm x 18mm
• 00840019915946: Variable Screws 4.5mm x 16mm
• 00840019915939: Variable Blunt Screws 4.5mm x 14mm
• 00840019915922: Variable Screws 4.5mm x 14mm
• 00840019915915: Variable Blunt Screws 4.5mm x 12mm
• 00840019915908: Variable Screws 4.5mm x 12mm
• 00840019915892: Variable Blunt Screws 4mm x 20mm
• 00840019915878: Variable Blunt Screws 4mm x 18mm
• 00840019915861: Variable Screws 4mm x 18mm