SureLOK MIS 3L 63-CP-8500

GUDID 00840019905749

Pedicle Screw Ø8.5 x 100mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019905749
• NIH Device Record Key: fae63416-b112-43e9-b776-1e51224bd4bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureLOK MIS 3L
• Version Model Number: 63-CP-8500
• Catalog Number: 63-CP-8500
• 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	00840019905749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141397

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

[00840019905749]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-16
• Device Publish Date: 2019-04-08

On-Brand Devices [SureLOK MIS 3L]

• 00840019920322: Caddy, CL Straight Rod Ti, 35-90mm
• 00840019920315: Caddy, CL Straight Rod Ti, 100-150mm
• 00840019920292: Caddy, Straight Rod 100-150mm
• 00840019920285: Caddy, CL Curved Rod Titanium
• 00840019920278: Caddy, Curved Rod Titanium
• 00840019920261: Insturment Case w/ Pin Mat
• 00840019920254: Implant Case 2
• 00840019920247: Implant Case 1
• 00840019920223: Instrument Case - M
• 00840019920216: MIS 3L Serial Dilator, 24mm
• 00840019920209: MIS 3L Serial Dilator, 18mm
• 00840019920193: MIS 3L Serial Dilator, 13mm
• 00840019920179: CL Rod Inserter
• 00840019920162: Ring
• 00840019920155: CL Counter Torque Handle
• 00840019920148: Reduction Driver
• 00840019920131: Reducer Dock
• 00840019920124: Compression-Distraction Arm B2
• 00840019920117: Compression-Distraction Arm B1
• 00840019920100: Compression-Distraction Arm A
• 00840019920094: Bifurcated Tap, 8.5mm
• 00840019920087: Bifurcated Tap, 7.5mm
• 00840019920070: Bifurcated Tap, 6.5mm
• 00840019920063: Bifurcated Tap, 5.5mm
• 00840019920056: Guide Wire Inserter/Extractor
• 00840019920032: Counter Torque Handle
• 00840019920025: Compressor-Distractor Arm B
• 00840019920018: Compressor-Distractor Arm A
• 00840019920001: Reducer Extender
• 00840019919999: Rod Reducer
• 00840019919982: C-Torque, Sleeve
• 00840019919975: Bottle Cap
• 00840019919951: Torque Drive Shaft
• 00840019919944: Rod Inserter, Side Load
• 00840019919920: Percutaneous Screwdriver, Short
• 00840019919913: Tower Sleeve
• 00840019919906: Ratcheting Palm Handle
• 00840019919883: Tap Dilator
• 00840019920308: Caddy, Straight Rod 35-90mm
• 00840019920230: Instrument Case
• 00840019920186: MIS 3L Serial Dilator, 8mm
• 00840019920049: T-Handle, Reduction Tower
• 00840019919968: Tower Tube Removal Tool
• 00840019919937: Rod Inserter Tightener
• 00840019919890: Biforcated Taps
• 00840019905749: Pedicle Screw Ø8.5 x 100mm
• 00840019905732: Pedicle Screw Ø8.5 x 90mm
• 00840019905725: Pedicle Screw Ø8.5 x 80mm
• 00840019905718: Pedicle Screw Ø8.5 x 70mm
• 00840019905701: Pedicle Screw Ø8.5 x 60mm