OPTIMA™ ZS Spinal Hook System

GUDID 08800015940726

U&I CORPORATION

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	08800015940726
NIH Device Record Key	da47bab3-1387-4735-9570-5335c3441799
Commercial Distribution Status	In Commercial Distribution
Brand Name	OPTIMA™ ZS Spinal Hook System
Version Model Number	SH1908
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.
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	08800015940726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031595

FDA Product Code

KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL