Kyocera Medical Technologies, Inc. 1111-653-080

GUDID 00841523130993

Polyaxial Screw 6.5mm diameter 80mm length for use with a 5.5mm Rod

KYOCERA MEDICAL TECHNOLOGIES, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841523130993
• NIH Device Record Key: f10dc8bc-539a-47d8-acda-36af1a2cb106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kyocera Medical Technologies, Inc.
• Version Model Number: S 100
• Catalog Number: 1111-653-080
• 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: 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	00841523130993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111940

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

[00841523130993]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-20
• Device Publish Date: 2019-01-16

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