LUMIS™

GUDID 03663136006673

ROD HOLDER

SPINEVISION

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03663136006673
• NIH Device Record Key: 3ff45aa9-4738-45e0-908f-b6cf46f53c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIS™
• Version Model Number: MS1-A271
• Company DUNS: 390377518
• Company Name: SPINEVISION
• Device Count: 1
• DM Exempt: false
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136006673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112607

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

[03663136006673]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-01-20
• Device Publish Date: 2015-10-21

On-Brand Devices [LUMIS™]

• 03663136020181: Ti 6.0 mm x 135 mm PRE-BENT PERCUTANEOUS ROD
• 03663136018782: Ø8mm CANNULATED TAP
• 03663136007809: MULTI-AXIAL SCREW Ø 8.5mm L 60mm
• 03663136007670: MULTI-AXIAL SCREW Ø 6.5mm L 55mm
• 03663136006949: MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 45mm
• 03663136006925: MULTI-AXIAL SCREW, DIAMETER 5.5mm, LENGTH 35mm
• 03663136007793: MULTI-AXIAL SCREW Ø 8.5mm L 55mm
• 03663136007724: MULTI-AXIAL SCREW Ø 7.5mm L 50mm
• 03663136007595: MULTI-AXIAL SCREW Ø 5.5mm L 45mm
• 03663136007540: GUIDE WIRE DIAMETER 1.4mm, LENGTH 500mm
• 03663136007366: Ti 6.0 mm x 100 mm PRE-BENT PERCUTANEOUS ROD
• 03663136007335: Ti 6.0 mm x 85 mm STRAIGHT PERCUTANEOUS ROD
• 03663136007274: Ti 6.0 mm x 70 mm STRAIGHT PERCUTANEOUS ROD
• 03663136006987: MULTI-AXIAL SCREW, DIAMETER 6.5mm, LENGTH 40mm
• 03663136006628: INDEX RING FOR SETSCREW HOLDER
• 03663136006611: SETSCREW HOLDER
• 03663136007755: MULTI-AXIAL SCREW Ø 8.5mm L35mm
• 03663136027654: Prebent percutaneous rod 6.0mm x 35mm
• 03663136027647: Prebent percutaneous rod 6.0mm x 30mm
• 03663136027630: Straight percutaneous rod 6.0mm x 35mm
• 03663136027623: Straight percutaneous rod 6.0mm x 30mm
• 03663136023670: LUMIS™ INSERT FOR INSTRUMENTS
• 03663136020174: Ti 6.0 mm x 125 mm PRE-BENT PERCUTANEOUS ROD
• 03663136020167: Ti 6.0 mm x 115 mm PRE-BENT PERCUTANEOUS ROD
• 03663136020150: Ti 6.0 mm x 105 mm PRE-BENT PERCUTANEOUS ROD
• 03663136020143: Ti 6.0 mm x 95 mm PRE-BENT PERCUTANEOUS ROD
• 03663136020136: Ti 6.0 mm x 135 mm STRAIGHT PERCUTANEOUS ROD
• 03663136020129: Ti 6.0 mm x 125 mm STRAIGHT PERCUTANEOUS ROD
• 03663136020112: Ti 6.0 mm x 115 mm STRAIGHT PERCUTANEOUS ROD
• 03663136020105: Ti 6.0 mm x 105 mm STRAIGHT PERCUTANEOUS ROD
• 03663136020099: Ti 6.0 mm x 95 mm STRAIGHT PERCUTANEOUS ROD
• 03663136020082: MULTI-AXIAL SCREW, DIAMETER 6.5mm, LENGTH 60mm
• 03663136008172: MOFALSEBLOC SCREW, Ø 8.5mm, L 90mm
• 03663136008165: MOFALSEBLOC SCREW, Ø 8.5mm, L 85mm
• 03663136008158: MOFALSEBLOC SCREW, Ø 8.5mm, L 80mm
• 03663136008141: MOFALSEBLOC SCREW, Ø 8.5mm, L 75mm
• 03663136008103: MOFALSEBLOC SCREW, Ø 8.5mm, L 55mm
• 03663136008097: MOFALSEBLOC SCREW, Ø 8.5mm, L 50mm
• 03663136008073: MOFALSEBLOC SCREW, Ø 8.5mm, L 40mm
• 03663136008066: MOFALSEBLOC SCREW, Ø 8.5mm, L 35mm
• 03663136008059: MOFALSEBLOC SCREW, Ø 7.5mm, L 60mm
• 03663136008042: MOFALSEBLOC SCREW, Ø 7.5mm, L 55mm
• 03663136008035: LUMIS™MOFALSEBLOC SCREW, Ø 7.5mm, L 50mm
• 03663136008028: MOFALSEBLOC SCREW, Ø 7.5mm, L 45mm
• 03663136008011: MOFALSEBLOC SCREW, Ø 7.5mm, L 40mm
• 03663136007991: MOFALSEBLOC SCREW, Ø 6.5mm, L 60mm
• 03663136007984: MOFALSEBLOC SCREW, Ø 6.5mm, L 55mm
• 03663136007977: MOFALSEBLOC SCREW, Ø 6.5mm, L 50mm
• 03663136007960: MOFALSEBLOC SCREW, Ø 6.5mm, L 45mm
• 03663136007953: MOFALSEBLOC SCREW, Ø 6.5mm, L 40mm