SURE LOK (TM) 43-TL-6550

GUDID 00815362022863

MD MAX TRIPLE LEAD 6.5 x 50MM (QTY 13)

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: 00815362022863
• NIH Device Record Key: d6b666d4-3bcf-405d-85ab-aa10965ed944
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURE LOK (TM)
• Version Model Number: 7225PS
• Catalog Number: 43-TL-6550
• 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	00815362022863 [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

[00815362022863]

Moist Heat or Steam Sterilization

[00815362022863]

Moist Heat or Steam Sterilization

[00815362022863]

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: 2016-11-01

On-Brand Devices [SURE LOK (TM) ]

• 00815362023013: MD MAX TRIPLE LEAD 7.5 x 55MM (QTY 23)
• 00815362023006: MD MAX TRIPLE LEAD 7.5 x 55MM (QTY 19)
• 00815362022993: MD MAX TRIPLE LEAD 7.5 x 50MM (QTY 20)
• 00815362022986: MD MAX TRIPLE LEAD 7.5 x 45MM (QTY 19)
• 00815362022979: MD MAX TRIPLE LEAD 7.5 x 50MM (QTY 25)
• 00815362022962: MD MAX TRIPLE LEAD 7.5 x 45MM (QTY 20)
• 00815362022955: MD MAX TRIPLE LEAD 7.5x45m (QTY 27)
• 00815362022948: MD MAX TRIPLE LEAD 7.5x40MM (QTY15)
• 00815362022931: MD MAX TRIPLE LEAD 7.5x40mm (QTY 9)
• 00815362022924: MD MAX TRIPLE LEAD 7.5x35mm (QTY 22)
• 00815362022917: MD MAX TRIPLE LEAD 7.5x35mm (QTY 28)
• 00815362022900: MD MAX TRIPLE LEAD 6.5 x 55MM (QTY 21)
• 00815362022894: MD MAX TRIPLE LEAD 6.5x55mm (QTY 24)
• 00815362022887: MD MAX TRIPLE LEAD SCREW 6.5 x 55MM (QTY 62)
• 00815362022870: MD MAX TRIPLE LEAD 6.5 x 55 MM (QTY 23)
• 00815362022863: MD MAX TRIPLE LEAD 6.5 x 50MM (QTY 13)
• 00815362022856: MD MAX TRIPLE LEAD 6.5x50MM (QTY 46)
• 00815362022849: MD MAXTRIPLE LEAD 5.5x55MM (QTY 9)
• 00815362022832: MD MAX TRIPLE LEAD 5.5x55MM (QTY 40)
• 00815362022825: MD MAX TRIPLE LEAD 5.5 x 50 MM (QTY 28)