M6-C CIK-203-08

GUDID 00812388032548

M6-C Single Use, Disposable Instrumentation: Disc Placement Kit, Size: 6L

Spinal Kinetics, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00812388032548
• NIH Device Record Key: f5fcb280-f9e5-46ac-9b2d-513ea15ee3a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M6-C
• Version Model Number: 1503-2030.90
• Catalog Number: CIK-203-08
• Company DUNS: 171513125
• Company Name: Spinal Kinetics, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812388032548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241117

FDA Product Code

• QLQ: Manual Instruments Designed For Use With Total Disc Replacement Devices

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: 2024-09-17
• Device Publish Date: 2024-09-09

On-Brand Devices [M6-C]

• 00812388030087: Artificial Cervical Disc, 7LL (7mm H x 17mm W x 16mm D)
• 00812388030070: Artificial Cervical Disc, 7L (7mm H x 17mm W x 14mm D)
• 00812388030063: Artificial Cervical Disc, 7ML (7mm H x 15mm W x 15mm D)
• 00812388030056: Artificial Cervical Disc, 7M (7mm H x 15mm W x 12.5mm D)
• 00812388030049: Artificial Cervical Disc, 6LL (6mm H x 17mm W x 16mm D)
• 00812388030032: Artificial Cervical Disc, 6L (6mm H x 17mm W x 14mm D)
• 00812388030025: Artificial Cervical Disc, 6ML (6mm H x 15mm W x 15mm D)
• 00812388030018: Artificial Cervical Disc, 6M (6mm H x 15mm W x 12.5mm D)
• 00812388030476: Instrument Kit, G6
• 00812388030469: Instrument Tray, SS, G6
• 00812388030452: Acute Disc Removal Tool, L/LL, G6
• 00812388030445: Acute Disc Removal Tool, M/ML, G6
• 00812388030438: Offset Tamp, G6
• 00812388030421: Inserter, LL, G6
• 00812388030414: Inserter, L, G6
• 00812388030407: Inserter, ML, G6
• 00812388030391: Inserter, M, G6
• 00812388030384: Slide Hammer, G6
• 00812388030377: Fin Cutter, 7LL (7mm H x 17mm W x 16mm D), G6
• 00812388030360: Fin Cutter, 7L (7mm H x 17mm W x 14mm D), G6
• 00812388030353: Fin Cutter, 7ML (7mm H x 15mm W x 15mm D), G6
• 00812388030346: Fin Cutter, 7M (7mm H x 15mm W x 12.5mm D), G6
• 00812388030339: Fin Cutter, 6LL (6mm H x 17mm W x 16mm D), G6
• 00812388030322: Fin Cutter, 6L (6mm H x 17mm W x 14mm D), G6
• 00812388030315: Fin Cutter, 6ML (6mm H x 15mm W x 15mm D), G6
• 00812388030308: Fin Cutter, 6M (6mm H x 15mm W x 12.5mm D), G6
• 00812388030292: Mallet, G6
• 00812388030285: Trial Handle, G6
• 00812388030278: Trial Head, 7LL (7mm H x 17mm W x 16mm D), G6
• 00812388030261: Trial Head, 7L (7mm H x 17mm W x 14mm D), G6
• 00812388030254: Trial Head, 7ML (7mm H x 15mm W x 15mm D), G6
• 00812388030247: Trial Head, 7M (7mm H x 15mm W x 12.5mm D), G6
• 00812388030230: Trial Head, 6LL (6mm H x 17mm W x 16mm D), G6
• 00812388030223: Trial Head, 6L (6mm H x 17mm W x 14mm D), G6
• 00812388030216: Trial Head, 6ML (6mm H x 15mm W x 15mm D), G6
• 00812388030209: Trial Head, 6M (6mm H x 15mm W x 12.5mm D), G6
• 00812388030193: Footprint Template, L/LL, G6
• 00812388030186: Footprint Template, M/ML, G6
• 00812388030179: Intervertebral Distractor, G6
• 00812388030162: Distractor Spacer, G6
• 00812388030155: Paddle Distractor, G6
• 00812388030148: Cervical Retainer Locking Nut
• 00812388030131: Retainer, G6
• 00812388030124: Pin Driver, G6
• 00812388030117: Cervical Retainer Pin, 16mm
• 00812388030100: Cervical Retainer Pin, 14mm
• 00812388030094: Cervical Retainer Pin, 12mm
• 00812388031312: M6-C Implant Case Kit – Ancillary
• 00812388031305: M6-C Implant Case Kit – Standard
• 00812388031299: Instrument Tray, SS, G7