I.CO.S ICOS4INSTSET

GUDID 10381780064411

The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. The I.CO.S screw is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation. This set includes I.CO.S screws that are 4mm in diameter. Instruments are also provided.

NEWDEAL

General internal orthopaedic fixation system implantation kit

Primary Device ID	10381780064411
NIH Device Record Key	91f8816c-1259-441f-be0f-c55063a0ffe6
Commercial Distribution Discontinuation	2023-03-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	I.CO.S
Version Model Number	ICOS4INSTSET
Catalog Number	ICOS4INSTSET
Company DUNS	536935331
Company Name	NEWDEAL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780064411 [Primary]
HIBCC	M248ICOS4INSTSET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K011821

FDA Product Code

HWC	Screw, fixation, bone