The Y3 Locking Trochanteric Plating System Y3P-IML-185

GUDID 07540194006202

Y3 PLATE 185MM - LEFT

Pega Medical Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Primary Device ID	07540194006202
NIH Device Record Key	26abf238-1839-46ca-aaf2-ae3002c37b37
Commercial Distribution Status	In Commercial Distribution
Brand Name	The Y3 Locking Trochanteric Plating System
Version Model Number	Y3P-IML-185
Catalog Number	Y3P-IML-185
Company DUNS	257315713
Company Name	Pega Medical Inc
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	false
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

Customer Support Contacts

Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com
Phone	+1(450)688-5144
Email	egarcia@pegamedical.com

Device Dimensions

Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter
Length	185 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature
Special Storage Condition, Specify	Between 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540194006202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163003

FDA Product Code

HRS	Plate, fixation, bone