VALEO

GUDID 00841732160057

Valeo TL 30x11 14 6 deg TEXTURED

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732160057
• NIH Device Record Key: 721ef801-6eec-4381-88e6-f6833b3366b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALEO
• Version Model Number: 11.011.1014
• Company DUNS: 080138504
• Company Name: CTL MEDICAL CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732160057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091278

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [VALEO]

• 00841732154452: VALEO C 16x12, 7, 6deg, TEXTURED
• 00841732144941: VALEO Corpectomy 16x12, 19, 6deg
• 00841732144934: VALEO Corpectomy 16x12, 20, 6deg
• 00841732144927: VALEO Corpectomy 16x12, 21, 6deg
• 00841732144910: VALEO Corpectomy 16x12, 24, 6deg
• 00841732144903: VALEO C 17x14, 10, 6deg, TEXTURED
• 00841732144897: VALEO Corpectomy 17x14, 20, 6deg
• 00841732144880: VALEO Corpectomy 17x14, 21, 6deg
• 00841732144873: VALEO Corpectomy 17x14, 22, 6deg
• 00841732144866: VALEO Corpectomy 17x14, 23, 6deg
• 00841732144859: VALEO TL 30x11, 9, 6deg, TEXTURED
• 00841732144842: VALEO TL 30x11, 10, 6deg, TEXTURED
• 00841732144835: VALEO TL 30x11, 11, 6deg, TEXTURED
• 00841732144828: VALEO TL 30x11, 12, 6deg, TEXTURED
• 00841732144545: VALEO C 16x12, 6, 6deg, TEXTURED
• 00841732144484: VALEO C 16x12, 5, 6deg TEXTURED
• 90841732128111: Osteotome Straight, 12
• 00841732160057: Valeo TL 30x11 14 6 deg TEXTURED
• 00841732160040: Valeo TL 30x11 13 6 deg TEXTURED
• 00841732160033: Valeo TL 30x11 8 6 deg TEXTURED
• 00841732160026: Valeo TL 30x11 7 6 deg TEXTURED
• 00841732160002: VALEO C 17x14 7 6 deg TEXTURED
• 00841732159990: VALEO C 17x14 6 6 deg TEXTURED
• 00841732159983: VALEO C 17x14 5 6 deg TEXTURED
• 00841732159648: Left Cutting Cup Long Curette
• 00841732159174: Valeo Rod, ø5.5mm x 80mm, Straight
• 00841732159167: Valeo Rod, ø5.5mm x 150mm, Straight
• 00841732159150: Valeo Rod, ø5.5mm x 40mm, Curved
• 00841732159143: Valeo Rod, ø5.5mm x 60mm, Curved
• 00841732159136: Valeo Rod, ø5.5mm x 80mm, Curved
• 00841732159129: Valeo PL, 9x21 , 6°, 7mm with Alternative Texture
• 00841732159112: Valeo PL, 9x21 , 6°, 8mm with Alternative Texture
• 00841732159105: Valeo PL, 9x21 , 6°, 9mm with Alternative Texture
• 00841732159099: Valeo PL, 9x21 , 6°, 10mm with Alternative Texture
• 00841732159082: Valeo PL, 9x21 , 6°, 11mm with Alternative Texture
• 00841732155824: Valeo VBR - C, 17x14, 6°, 8mm
• 00841732155817: Valeo VBR - C, 16x12, 6°, 9mm
• 00841732154728: Valeo C 17x14 12mm 0 deg
• 00841732154711: Valeo C 17x14 11mm 0 deg
• 00841732154704: Valeo C 17x14 10mm 0 deg
• 00841732154698: Valeo C 17x14 9mm 0 deg
• 00841732154681: Valeo C 17x14 8mm 0 deg
• 00841732154674: Valeo C 17x14 7mm 0 deg
• 00841732154667: Valeo C 17x14 6mm 0 deg
• 00841732154650: Valeo C 17x14 5mm 0 deg
• 00841732154629: Valeo C 17x14 9mm 6 deg
• 00841732154575: Valeo C 16x12 12mm 0 deg
• 00841732154568: Valeo C 16x12 11mm 0 deg
• 00841732154551: Valeo C 16x12 10mm 0 deg
• 00841732154544: Valeo C 16x12 9mm 0 deg