S-LOK PSS System 43-TL-5550

GUDID 00815362022818

Ø5.5 MD-Max™ Triple Lead Screw 50mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00815362022818
• NIH Device Record Key: bd262e69-d757-48b6-ab3a-1456f81beb2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-LOK PSS System
• Version Model Number: 43-TL-5550
• Catalog Number: 43-TL-5550
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815362022818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122931

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00815362022818]

Moist Heat or Steam Sterilization

[00815362022818]

Moist Heat or Steam Sterilization

[00815362022818]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-25
• Device Publish Date: 2016-11-01

On-Brand Devices [S-LOK PSS System ]

• 00815362022818: Ø5.5 MD-Max™ Triple Lead Screw 50mm
• 00840019915229: Ø6.5 MD-Max™ Triple Lead Screw 45mm