JULIET INSTRUMENTATION JUL-IN 07 16-N

GUDID 07640151110765

Lateral Trial, 17mm,H10

SpineArt SA

Spinal implant trial

• Primary Device ID: 07640151110765
• NIH Device Record Key: ba26cfe3-be44-4d92-a7f1-278869baaf2e
• Commercial Distribution Discontinuation: 2018-02-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: JULIET INSTRUMENTATION
• Version Model Number: JUL-IN 07 16-N
• Catalog Number: JUL-IN 07 16-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: true
• 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	07640151110765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161888

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

[07640151110765]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-02-08

On-Brand Devices [JULIET INSTRUMENTATION]

• 07640178982451: RASP
• 07640178982444: UP ANGLE FLAT COBB 17MM
• 07640178982437: FLAT COBB 17MM
• 07640178980792: Lateral Trial, 17mm,H16
• 07640178980785: Lateral Trial, 17mm,H14
• 07640178980778: Lateral Trial, 17mm,H12
• 07640178980761: Lateral Trial, 17mm,H10
• 07640178980754: Lateral Trial, 17mm,H08-6°
• 07640178980075: 40° WEDGE RASP, BAYONETED
• 07640178980068: 30° WEDGE RASP, BAYONETED
• 07640178980044: CUP CURETTE - 13MM - ANGLED DOWN
• 07640178980037: CUP CURETTE - #4 - ANGLED DOWN
• 07640178980020: CUP CURETTE - #3 - ANGLED DOWN
• 07640178980013: CUP CURETTE - #2 - ANGLED DOWN
• 07640178973688: CUP CURETTE # 4 RIGHT 45 DEGREES
• 07640178973671: CUP CURETTE # 3 RIGHT 45 DEGREES
• 07640178973664: CUP CURETTE # 2 RIGHT 45 DEGREES
• 07640178973657: CUP CURETTE # 4 LEFT 45 DEGREES
• 07640178973640: CUP CURETTE # 2 LEFT 45 DEGREES
• 07640178973633: CUP CURETTE # 2 LEFT 45 DEGREES
• 07640178973626: CUP CURETTE # 4 ANGLED UP
• 07640178973619: CUP CURETTE # 3 ANGLED UP
• 07640178973602: CUP CURETTE # 2 ANGLED UP
• 07640178973596: CUP CURETTE # 4 STRAIGHT
• 07640178973589: CUP CURETTE # 3 STRAIGHT
• 07640178973572: CUP CURETTE # 2 STRAIGHT
• 07640178972735: Lateral Single Slide
• 07640178972711: Bayoneted Penfield Holder
• 07640178972704: Bayoneted Penfield
• 07640178972698: Cup Curette Down Angled #3
• 07640178972681: Cup Curette Straight #3
• 07640178972667: Lateral Trial, 17mm, H12
• 07640178972650: Lateral Trial, 17mm, H10
• 07640178972643: Lateral Trial, 17mm, H08
• 07640178972636: Lateral Trial, 17mm, H06
• 07640178972629: LATERAL PADDLE SHAVER
• 07640178972612: LATERAL PADDLE SHAVER
• 07640178972605: LATERAL PADDLE SHAVER
• 07640178972599: Paddle Shaver H10
• 07640178972582: LATERAL PADDLE SHAVER
• 07640151110796: Lateral Trial, 17mm,H16
• 07640151110789: Lateral Trial, 17mm,H14
• 07640151110772: Lateral Trial, 17mm,H12
• 07640151110765: Lateral Trial, 17mm,H10
• 07640151110758: Lateral Trial, 17mm,H08-6°
• 07640151109998: CUP CURETTE - 13MM - RIGHT 45 DEGREES
• 07640151109974: CUP CURETTE - 13MM - LEFT 45 DEGREES
• 07640151109950: CUP CURETTE - 13MM - ANGLED UP
• 07640151109943: CUP CURETTE - 14.5MM - STRAIGHT
• 07640151109936: CUP CURETTE - 13MM - STRAIGHT