OPTIMA™ ZS Transition Screw

GUDID 08800015941075

U&I CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800015941075
• NIH Device Record Key: c1846e90-f22a-4ea0-b8af-48b0a1684520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMA™ ZS Transition Screw
• Version Model Number: SD8055
• 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	08800015941075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071880

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

Moist Heat or Steam Sterilization

[08800015941075]

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: 2016-11-29

On-Brand Devices [OPTIMA™ ZS Transition Screw]

• 08800015941259: SDA7055
• 08800015941242: SDA7050
• 08800015941235: SDA7045
• 08800015941228: SDA7040
• 08800015941211: SDA7035
• 08800015941204: SDA7030
• 08800015941198: SDA6055
• 08800015941181: SDA6050
• 08800015941174: SDA6045
• 08800015941167: SDA6040
• 08800015941150: SDA6035
• 08800015941143: SDA6030
• 08800015941136: SDA5055
• 08800015941129: SDA5050
• 08800015941112: SDA5045
• 08800015941105: SDA5040
• 08800015941099: SDA5035
• 08800015941082: SDA5030
• 08800015941075: SD8055
• 08800015941068: SD8050
• 08800015941051: SD8045
• 08800015941044: SD8040
• 08800015941037: SD8035
• 08800015941020: SD8030
• 08800015941013: SD7055
• 08800015941006: SD7050
• 08800015940993: SD7045
• 08800015940986: SD7040
• 08800015940979: SD7035
• 08800015940962: SD7030
• 08800015940955: SD6055
• 08800015940948: SD6050
• 08800015940931: SD6045
• 08800015940924: SD6040
• 08800015940917: SD6035
• 08800015940900: SD6030
• 08800015940894: SD5055
• 08800015940887: SD5050
• 08800015940870: SD5045
• 08800015940863: SD5040
• 08800015940856: SD5035
• 08800015940849: SD5030
• 08800015940832: SD4055
• 08800015940825: SD4050
• 08800015940818: SD4045
• 08800015940801: SD4040
• 08800015940795: SD4035
• 08800015940788: SD4030