Kyocera Medical Technologies, Inc. 1040-201-316

GUDID 00841523159123

Skyway 1-Level Anterior Cervical Plate, 3-16mm

KYOCERA MEDICAL TECHNOLOGIES, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00841523159123
• NIH Device Record Key: d1a34265-aabd-4601-a903-f4c326503dff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kyocera Medical Technologies, Inc.
• Version Model Number: Skyway ACP
• Catalog Number: 1040-201-316
• Company DUNS: 116995646
• Company Name: KYOCERA MEDICAL TECHNOLOGIES, 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	00841523159123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231766

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-11-20
• Device Publish Date: 2024-01-08

On-Brand Devices [Kyocera Medical Technologies, Inc.]

• 00841523150472: Medium Serrated Cup Curette
• 00841523122523: 12mm Trial, 34 X 28, 12°Lordosis
• 00841523122516: 11mm Trial, 34 X 28, 12°Lordosis
• 00841523122509: 21mm Trial, 30 X 26, 12°Lordosis
• 00841523122493: 20mm Trial, 30 X 26, 12°Lordosis
• 00841523122486: 19mm Trial, 30 X 26, 12°Lordosis
• 00841523122479: 18mm Trial, 30 X 26, 12°Lordosis
• 00841523122462: 17mm Trial, 30 X 26, 12°Lordosis
• 00841523122455: 16mm Trial, 30 X 26, 12°Lordosis
• 00841523122448: 15mm Trial, 30 X 26, 12°Lordosis
• 00841523122431: 14mm Trial, 30 X 26, 12°Lordosis
• 00841523122424: 13mm Trial, 30 X 26, 12°Lordosis
• 00841523122400: 11mm Trial, 30 X 26, 12°Lordosis
• 00841523122394: 21mm Trial, 38 X 30, 7°Lordosis
• 00841523122387: 20mm Trial, 38 X 30, 7°Lordosis
• 00841523122370: 19mm Trial, 38 X 30, 7°Lordosis
• 00841523122363: 18mm Trial, 38 X 30, 7°Lordosis
• 00841523122356: 17mm Trial, 38 X 30, 7°Lordosis
• 00841523122349: 16mm Trial, 38 X 30, 7°Lordosis
• 00841523122332: 15mm Trial, 38 X 30, 7°Lordosis
• 00841523122325: 14mm Trial, 38 X 30, 7°Lordosis
• 00841523122318: 13mm Trial, 38 X 30, 7°Lordosis
• 00841523122301: 12mm Trial, 38 X 30, 7°Lordosis
• 00841523122295: 11mm Trial, 38 X 30, 7°Lordosis
• 00841523122288: 21mm Trial, 34 X 28, 7°Lordosis
• 00841523122271: 20mm Trial, 34 X 28, 7°Lordosis
• 00841523122264: 19mm Trial, 34 X 28, 7°Lordosis
• 00841523122257: 18mm Trial, 34 X 28, 7°Lordosis
• 00841523122240: 17mm Trial, 34 X 28, 7°Lordosis
• 00841523122233: 16mm Trial, 34 X 28, 7°Lordosis
• 00841523122226: 15mm Trial, 34 X 28, 7°Lordosis
• 00841523122219: 14mm Trial, 34 X 28, 7°Lordosis
• 00841523122202: 13mm Trial, 34 X 28, 7°Lordosis
• 00841523122196: 12mm Trial, 34 X 28, 7°Lordosis
• 00841523122189: 11mm Trial, 34 X 28, 7°Lordosis
• 00841523122172: 21mm Trial, 30 X 26, 7°Lordosis
• 00841523122165: 20mm Trial, 30 X 26, 7°Lordosis
• 00841523122158: 19mm Trial, 30 X 26, 7°Lordosis
• 00841523122141: 18mm Trial, 30 X 26, 7°Lordosis
• 00841523122134: 17mm Trial, 30 X 26, 7°Lordosis
• 00841523122127: 16mm Trial, 30 X 26, 7°Lordosis
• 00841523122110: 15mm Trial, 30 X 26, 7°Lordosis
• 00841523122103: 14mm Trial, 30 X 26, 7°Lordosis
• 00841523122097: 13mm Trial, 30 X 26, 7°Lordosis
• 00841523122080: 12mm Trial, 30 X 26, 7°Lordosis
• 00841523122073: 11mm Trial, 30 X 26, 7°Lordosis
• 00841523122066: Paddle Sizer 38 X 30
• 00841523122059: Paddle Sizer 34 X 28
• 00841523122042: Paddle Sizer 30 X 26
• 00841523122035: 21mm Bullet Nose Distractor