The Y3 Locking Trochanteric Plating System Y3P-LS45-22

GUDID 07540194006318

Ø4.5 Distal Locking screw - 22mm

Pega Medical Inc

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

• Primary Device ID: 07540194006318
• NIH Device Record Key: e36597b0-567d-45ea-8b8c-60cd94d74c69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Y3 Locking Trochanteric Plating System
• Version Model Number: Y3P-LS45-22
• Catalog Number: Y3P-LS45-22
• 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

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 22 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540194006318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163003

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

[07540194006318]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-12

On-Brand Devices [The Y3 Locking Trochanteric Plating System]

• 07540194006516: INSTRUMENT & IMPLANT CASE - FULL
• 07540194006509: Ø3.5 GT Locking screw - 30mm
• 07540194006493: Ø3.5 GT Locking screw - 28mm
• 07540194006486: Ø3.5 GT Locking screw - 26mm
• 07540194006479: Ø3.5 GT Locking screw - 24mm
• 07540194006462: Ø3.5 GT Locking screw - 22mm
• 07540194006455: Ø3.5 GT Locking screw - 20mm
• 07540194006448: Ø3.5 GT Locking screw - 18mm
• 07540194006431: Ø3.5 GT Locking screw - 16mm
• 07540194006424: Ø3.5 GT Locking screw - 14mm
• 07540194006417: Ø3.5 GT Locking screw - 12mm
• 07540194006400: Ø3.5 GT Locking screw - 10mm
• 07540194006394: Ø4.5 Distal Locking screw - 50mm
• 07540194006387: Ø4.5 Distal Locking screw - 45mm
• 07540194006370: Ø4.5 Distal Locking screw - 40mm
• 07540194006363: Ø4.5 Distal Locking screw - 35mm
• 07540194006356: Ø4.5 Distal Locking screw - 30mm
• 07540194006349: Ø4.5 Distal Locking screw - 28mm
• 07540194006332: Ø4.5 Distal Locking screw - 26mm
• 07540194006325: Ø4.5 Distal Locking screw - 24mm
• 07540194006318: Ø4.5 Distal Locking screw - 22mm
• 07540194006301: Ø4.5 Distal Locking screw - 20mm
• 07540194006295: Ø4.5 Distal Locking screw - 18mm
• 07540194006288: Ø4.5 Distal Locking screw - 16mm
• 07540194006271: Ø4.5 Distal Locking screw - 14mm
• 07540194006264: Y3 PLATE 285MM - RIGHT
• 07540194006257: Y3 PLATE 235MM - RIGHT
• 07540194006240: Y3 PLATE 185MM - RIGHT
• 07540194006233: Y3 PLATE 135MM - RIGHT
• 07540194006226: Y3 PLATE 285MM - LEFT
• 07540194006219: Y3 PLATE 235MM - LEFT
• 07540194006202: Y3 PLATE 185MM - LEFT
• 07540194006196: Y3 PLATE 135MM - LEFT
• 07540194006189: Ø4.5 Distal Compression screw - 50mm
• 07540194006172: Ø4.5 Distal Compression screw - 45mm
• 07540194006165: Ø4.5 Distal Compression screw - 40mm
• 07540194006158: Ø4.5 Distal Compression screw - 35mm
• 07540194006141: Ø4.5 Distal Compression screw - 30mm
• 07540194006134: Ø4.5 Distal Compression screw - 28mm
• 07540194006127: Ø4.5 Distal Compression screw - 26mm
• 07540194006110: Ø4.5 Distal Compression screw - 24mm
• 07540194006103: Ø4.5 Distal Compression screw - 22mm
• 07540194006097: Ø4.5 Distal Compression screw - 20mm
• 07540194006080: Ø4.5 Distal Compression screw - 18mm
• 07540194009401: Ø4.5 Distal Compression screw - 16mm
• 07540194009395: Ø4.5 Distal Compression screw - 14mm