AccuFit Lateral Plate System 58-BK-1005

GUDID 00840019965903

AccuFit 2 Hole Lateral Plate Kit

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840019965903
• NIH Device Record Key: 7d6fc3a2-0211-49ff-b3e8-5e8a2bd96b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuFit Lateral Plate System
• Version Model Number: 58-BK-1005
• Catalog Number: 58-BK-1005
• 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: true
• Device Combination Product: false
• Single Use: false
• 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	00840019965903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220324

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

[00840019965903]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [AccuFit Lateral Plate System]

• 00840019919876: AccuFit® LP Case
• 00840019919852: Lock Unlock Driver
• 00840019919845: Locking Screw Driver
• 00840019919814: Plate Holder
• 00840019919807: 5in-lb Torque Limiting Handle
• 00840019919791: Ratcheting AO Handle
• 00840019919784: Adjustable Guide
• 00840019919777: Angled Trocar Awl
• 00840019919760: Flexible Trocar Awl
• 00840019919746: Flexible Bevel Awl
• 00840019919739: Bevel Awl
• 00840019919722: Flexible Drill
• 00840019919715: Drill
• 00840019919869: 7.5mm Up-biting Rongeur, Disc 13"
• 00840019919838: Flexible Bone Screw Driver
• 00840019919821: Bone Screw Driver
• 00840019919753: Trocar Awl
• 00840019904643: Locking Screw
• 00840019904636: Ø6.5mm Variable Screw, 60mm
• 00840019904629: Ø6.5mm Variable Screw, 55mm
• 00840019904612: Ø6.5mm Variable Screw, 50mm
• 00840019904605: Ø6.5mm Variable Screw, 45mm
• 00840019904599: Ø6.5mm Variable Screw, 40mm
• 00840019904582: Ø6.5mm Variable Screw, 35mm
• 00840019904575: 58-VS-6530
• 00840019904568: Ø5.5mm Variable Screw, 60mm
• 00840019904551: Ø5.5mm Variable Screw, 55mm
• 00840019904544: Ø5.5mm Variable Screw, 50mm
• 00840019904537: Ø5.5mm Variable Screw, 45mm
• 00840019904520: Ø5.5mm Variable Screw, 40mm
• 00840019904513: Ø5.5mm Variable Screw, 35mm
• 00840019904506: Ø5.5mm Variable Screw, 30mm
• 00840019904490: 38mm Plate
• 00840019904483: 36mm Plate
• 00840019904476: 34mm Plate
• 00840019904469: 32mm Plate
• 00840019904452: 30mm Plate
• 00815362025147: Ø5.5mm Variable Screw, 25mm
• 00815362023334: Ø6.5mm Variable Screw, 25mm
• 00840019936491: Instrument & Implant Kit
• 00840019967457: AccuFit 4 Hole Lateral Plate Kit
• 00840019967440: AccuFit 4 Hole Lateral Plate Caddy
• 00840019965910: Instrument & Implant Kit - 2 Hole Plate
• 00840019965903: AccuFit 2 Hole Lateral Plate Kit
• 00840019965897: AccuFit 2 Hole Lateral Plate Caddy
• 00840019965880: 2 Hole DTS Drill - 25mm
• 00840019965873: 2 Hole 7° DTS Guide Plate Holder
• 00840019965866: 2 Hole Forceps Plate Holder
• 00840019965859: AccuFit 2 Hole Lateral Plate - 36mm
• 00840019965842: AccuFit 2 Hole Lateral Plate - 34mm