Maxima™ ACP System

GUDID 08800015912099

U&I CORPORATION

Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system

Primary Device ID	08800015912099
NIH Device Record Key	b6f1c465-c0ff-4011-9a2d-97abfa361cba
Commercial Distribution Status	In Commercial Distribution
Brand Name	Maxima™ ACP System
Version Model Number	SC4010-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	08800015912099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K061002

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY