SURE-LOK (TM) 43-TL-5545

GUDID 00815362021767

Triple Lead Screw 5.5mmx45mm (qty. 25)

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: 00815362021767
• NIH Device Record Key: 0fd9e9f8-7579-4514-a765-be0545eb186c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURE-LOK (TM)
• Version Model Number: 9773PS
• Catalog Number: 43-TL-5545
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00815362021767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141397

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00815362021767]

Moist Heat or Steam Sterilization

[00815362021767]

Moist Heat or Steam Sterilization

[00815362021767]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-24

On-Brand Devices [SURE-LOK (TM)]

• 00815362021880: Triple Lead Screw 5.5mmx45mm (qty. 25)
• 00815362021842: Triple Lead Screw 6.5mmx40mm (qty. 167)
• 00815362021811: Triple Lead Screw 5.5mmx40mm (qty. 74)
• 00815362021798: Triple Lead Screw 6.5mmx45mm (qty. 50)
• 00815362021774: Triple Lead Screw 5.5mmx50mm (qty. 79)
• 00815362021767: Triple Lead Screw 5.5mmx45mm (qty. 25)
• 00815362021750: Triple Lead Screw 5.5mmx45mm (qty. 15)
• 00815362021712: TRIPLE LEAD SCREW 5.5MMx45mm (QTY: 23)
• 00815362021699: TRIPLE LEAD SCREW 5.5mmx40mm (qty. 26)
• 00815362021682: Triple Lead Screw 55mmX40mm (qty. 27)
• 00815362021675: Triple Lead Screw 5.5mmx35mm (qty. 20)
• 00815362021668: Triple Lead Screw 6.5mmx40mm (qty. 45)
• 00815362021644: TRIPLE LEAD SCREW 6.5mmx45 (qty. 83)