OPTIMA™ ZS Spinal Hook System

GUDID 08800015940757

U&I CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800015940757
• NIH Device Record Key: d38b7d3d-004f-4086-9970-612149fbb6e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMA™ ZS Spinal Hook System
• Version Model Number: SH1911
• Company DUNS: 688811082
• Company Name: U&I CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800015940757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031595

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

[08800015940757]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-17
• Device Publish Date: 2016-10-08

On-Brand Devices [OPTIMA™ ZS Spinal Hook System]

• 08800015940771: SH1915
• 08800015940764: SH1912
• 08800015940757: SH1911
• 08800015940740: SH1910
• 08800015940733: SH1909
• 08800015940726: SH1908
• 08800015940719: SH1907
• 08800015940702: SH1906
• 08800015940696: SH1905
• 08800015940689: SH1904
• 08800015940672: SH0509-A3