Maxima™ ACP System

GUDID 08800015912334

U&I CORPORATION

Intervertebral-body internal spinal fixation system

• Primary Device ID: 08800015912334
• NIH Device Record Key: a1a01a14-9bb2-460e-85e2-1ac497757114
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxima™ ACP System
• Version Model Number: SC4018-R
• 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	08800015912334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061002

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

Moist Heat or Steam Sterilization

[08800015912334]

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 [Maxima™ ACP System]

• 08800015957755: SCS1008
• 08800015957748: SCS1007
• 08800015957687: SCS1001
• 08800015957632: SC7190
• 08800015912846: SCA1108-S
• 08800015912839: SCA1104-S
• 08800015912822: SCA1100-S
• 08800015912815: SCA1096-S
• 08800015912808: SCA1092-S
• 08800015912792: SCA1088-S
• 08800015912785: SCA1085-S
• 08800015912778: SCA1082-S
• 08800015912761: SCA1079-S
• 08800015912754: SCA1076-S
• 08800015912747: SCA1073-S
• 08800015912730: SCA1070-S
• 08800015912723: SCA1068-S
• 08800015912716: SCA1066-S
• 08800015912709: SCA1064-S
• 08800015912693: SCA1062-S
• 08800015912686: SCA1060-S
• 08800015912679: SCA1058-S
• 08800015912662: SCA1056-S
• 08800015912655: SCA1054-S
• 08800015912648: SCA1052-S
• 08800015912631: SCA1050-S
• 08800015912624: SCA1048-S
• 08800015912617: SCA1046-S
• 08800015912600: SCA1044-S
• 08800015912594: SCA1042-S
• 08800015912587: SCA1040-S
• 08800015912570: SCA1038-S
• 08800015912563: SCA1036-S
• 08800015912556: SCA1034-S
• 08800015912549: SCA1034-E
• 08800015912532: SCA1032-S
• 08800015912525: SCA1032-E
• 08800015912518: SCA1030-S
• 08800015912501: SCA1030-E
• 08800015912495: SCA1028-S
• 08800015912488: SCA1028-E
• 08800015912471: SCA1026-S
• 08800015912464: SCA1026-E
• 08800015912457: SCA1024-S
• 08800015912440: SCA1024-E
• 08800015912433: SCA1022-S
• 08800015912426: SC4314-V
• 08800015912419: SC4312-V
• 08800015912402: SC4020-V
• 08800015912396: SC4020-R