OPTIMA™ ZS Spinal System

GUDID 08800037556035

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: 08800037556035
• NIH Device Record Key: b1da6197-ed1b-4cf6-b536-a422b4df0dd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMA™ ZS Spinal System
• Version Model Number: SG3645
• 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	08800037556035 [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

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

[08800037556035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-12

On-Brand Devices [OPTIMA™ ZS Spinal System]

• 08800015959124: SZS1065
• 08800015959841: SP0006
• 08800015959728: SZS1076
• 08800015959711: SZS1070
• 08800015959414: SZS1107
• 08800015959360: SZS1101
• 08800015959353: SZS1100
• 08800015959346: SZS1099
• 08800015959322: SZS1096
• 08800015959292: SZS1089
• 08800015959285: SZS1088
• 08800015959278: SZS1086
• 08800015959261: SZS1084
• 08800015959254: SZS1083
• 08800015959247: SZS1082
• 08800015959223: SZS1080
• 08800015959216: SZS1079
• 08800015959209: SZS1075
• 08800015959193: SZS1074
• 08800015959179: SZS1071
• 08800015959162: SZS1069
• 08800015959155: SZS1068
• 08800015959148: SZS1067
• 08800015959131: SZS1066
• 08800015959117: SZS1064
• 08800015959100: SZS1063
• 08800015959094: SZS1062
• 08800015959063: SZS1058
• 08800015959834: SI0120
• 08800015959476: SZS1113
• 08800015959452: SZS1111
• 08800015959438: SZS1109
• 08800015959407: SZS1106
• 08800015959377: SZS1102
• 08800015959483: SZS1114
• 08800015959421: SZS1108
• 08800015959391: SZS1105
• 08800015959384: SZS1103
• 08800015959339: SZS1098
• 08800015959315: SZS1094
• 08800015959308: SZS1090
• 08800015959230: SZS1081
• 08800015959049: SZS1050
• 08800015959704: SPZ004-D
• 08800015959698: SPZ004-C
• 08800015959681: SPZ004-B
• 08800015959674: SPZ004-A
• 08800015959667: SPZ004
• 08800015959650: SPZ003-F
• 08800015959643: SPZ003-E