MD-Max ULIF 43-TL-1055

GUDID 00840019915052

Ø10.5 MD-Max™ Triple Lead Screw 55mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019915052
• NIH Device Record Key: df56cec2-1d66-479f-8b77-47c54e4c3339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD-Max ULIF
• Version Model Number: 43-TL-1055
• Catalog Number: 43-TL-1055
• 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	00840019915052 [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

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

[00840019915052]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

On-Brand Devices [MD-Max ULIF]

• 00840019926072: 8.5mm MD-Max Triple Lead Tap
• 00840019926065: 7.5mm MD-Max™ Triple Lead Tap
• 00840019926058: 6.5mm MD-Max™ Triple Lead Tap
• 00840019926041: 5.5mm MD-Max™ Triple Lead Tap
• 00840019926034: Medial Blade Bar
• 00840019926027: Medial Blade Rack Assembly
• 00840019926010: Medial Retractor Blade, 110 mm
• 00840019926003: Medial Retractor Blade, 100 mm
• 00840019925990: Medial Retractor Blade, 90 mm
• 00840019925983: Medial Retractor Blade, 80 mm
• 00840019925976: Medial Retractor Blade, 70 mm
• 00840019925969: Medial Retractor Blade, 60 mm
• 00840019925952: Medial Retractor Blade, 50 mm
• 00840019925945: Medial Retractor Blade, 40 mm
• 00840019925938: Hexdriver
• 00840019925921: Drill, Pedicle Targeting
• 00840019925907: Torque Limiting T-Handle 36 in-lbs
• 00840019925891: Reusable Light Cable-Lumitex
• 00840019926157: MD-Max Bottle Cap Reducer
• 00840019926140: Contralateral Sleeve Assembly
• 00840019926133: Ipsilateral Sleeve Assembly, 100mm
• 00840019926126: Ipsilateral Sleeve Assembly, 80mm
• 00840019926119: Ipsilateral Sleeve Assembly, 60mm
• 00840019926102: Ipsilateral Sleeve Assembly, 40mm
• 00840019926096: Bilateral Retractor Assembly
• 00840019926089: Lumitex Light Source
• 00840019915427: Ø8.5 MD-Max™ Triple Lead Screw 60mm
• 00840019915410: Ø8.5 MD-Max™ Triple Lead Screw 55mm
• 00840019915403: Ø8.5 MD-Max™ Triple Lead Screw 50mm
• 00840019915397: Ø8.5 MD-Max™ Triple Lead Screw 45mm
• 00840019915380: Ø8.5 MD-Max™ Triple Lead Screw 40mm
• 00840019915373: Ø8.5 MD-Max™ Triple Lead Screw 35mm
• 00840019915366: Ø8.5 MD-Max™ Triple Lead Screw 30mm
• 00840019915359: Ø8.5 MD-Max™ Triple Lead Screw 25mm
• 00840019915342: Ø8.5 MD-Max™ Triple Lead Screw 100mm
• 00840019915335: 43-TL-7560
• 00840019915328: Ø7.5 MD-Max™ Triple Lead Screw 55mm
• 00840019915311: Ø7.5 MD-Max™ Triple Lead Screw 50mm
• 00840019915304: Ø7.5 MD-Max™ Triple Lead Screw 45mm
• 00840019915298: Ø7.5 MD-Max™ Triple Lead Screw 40mm
• 00840019915281: Ø7.5 MD-Max™ Triple Lead Screw 35mm
• 00840019915274: Ø7.5 MD-Max™ Triple Lead Screw 30mm
• 00840019915267: Ø7.5 MD-Max™ Triple Lead Screw 25mm
• 00840019915250: Ø6.5 MD-Max™ Triple Lead Screw 60mm
• 00840019915243: Ø6.5 MD-Max™ Triple Lead Screw 55mm
• 00840019915236: Ø6.5 MD-Max™ Triple Lead Screw 50mm
• 00840019915212: Ø6.5 MD-Max™ Triple Lead Screw 40mm
• 00840019915205: Ø6.5 MD-Max™ Triple Lead Screw 35mm
• 00840019915199: Ø6.5 MD-Max™ Triple Lead Screw 30mm
• 00840019915182: Ø6.5 MD-Max™ Triple Lead Screw 25mm