OPTIMA™ Spinal System

GUDID 08800037560674

U&I CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800037560674
• NIH Device Record Key: 565fab70-1d90-44f7-ac62-af5c0ffaddbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMA™ Spinal System
• Version Model Number: SGA2080
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800037560674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042928

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

[08800037560674]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-06
• Device Publish Date: 2023-02-25

On-Brand Devices [OPTIMA™ Spinal System]

• 08800015952545: SPZ003
• 08800015952538: SPZ002
• 08800015952521: SPZ001
• 08800015952514: SP003-D
• 08800015952507: SP003-C
• 08800015952491: SP003-B
• 08800015952484: SP003-A
• 08800015952477: SP003
• 08800015952460: SP002-D
• 08800015952453: SP002-C
• 08800015952446: SP002-B
• 08800015952439: SP002-A
• 08800015952422: SP002
• 08800015952415: SP001-E
• 08800015952408: SP001-D
• 08800015952392: SP001-C
• 08800015952385: SP001-B
• 08800015952378: SP001-A
• 08800015952361: SP001
• 08800015952354: SH0005
• 08800015952347: SH0004
• 08800015952330: SH0001
• 08800015952323: SZS1047
• 08800015952316: SZS1046
• 08800015952309: SZS1034
• 08800015952293: SZS1020
• 08800015952286: SZS1004
• 08800015952279: SPS1002
• 08800015952262: SP0043
• 08800015952255: SP0041
• 08800015952248: SP0040
• 08800015952231: SP0039
• 08800015952224: SP0038
• 08800015952217: SP0036
• 08800015952200: SP0035
• 08800015952194: SP0034
• 08800015952187: SP0033
• 08800015952170: SP0032
• 08800015952163: SP0031
• 08800015952156: SP0029
• 08800015952149: SP0028
• 08800015952132: SP0027
• 08800015952118: SP0023
• 08800015952101: SP0022
• 08800015952095: SP0021
• 08800015952088: SP0020
• 08800015952071: SP0019
• 08800015952064: SP0018
• 08800015952057: SP0017
• 08800015952040: SP0016