The Locking Pediatric Osteotomy Plate (LolliPOP) S POP-AB-45

GUDID 07540194005106

Blade, Adolescent 45mm

Pega Medical Inc

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

• Primary Device ID: 07540194005106
• NIH Device Record Key: d925d2f5-82cd-46f7-9bda-e305b0477a63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Locking Pediatric Osteotomy Plate (LolliPOP) S
• Version Model Number: POP-AB-45
• Catalog Number: POP-AB-45
• 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

• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 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	07540194005106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170704

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

[07540194005106]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-03

On-Brand Devices [The Locking Pediatric Osteotomy Plate (LolliPOP) S]

• 07540194006684: Locking Screw, Ø2.7 X 12mm
• 07540194006677: Locking Screw, Ø3.5 X 12mm
• 07540194006660: Locking Screw, Ø4.5 X 12mm
• 07540194006653: Polyaxial Compression Screw, Ø2.7 X 26mm
• 07540194006646: Polyaxial Compression Screw, Ø2.7 X 22mm
• 07540194006639: Polyaxial Compression Screw, Ø2.7 X 18mm
• 07540194006622: Polyaxial Compression Screw, Ø2.7 X 14mm
• 07540194006615: Polyaxial Compression Screw, Ø3.5 X 26mm
• 07540194006608: Polyaxial Compression Screw, Ø3.5 X 22mm
• 07540194006592: Polyaxial Compression Screw, Ø3.5 X 18mm
• 07540194006585: Polyaxial Compression Screw, Ø3.5 X 14mm
• 07540194006578: Polyaxial Compression Screw, Ø4.5 X 26mm
• 07540194006561: Polyaxial Compression Screw, Ø4.5 X 22mm
• 07540194006554: Polyaxial Compression Screw, Ø4.5 X 18mm
• 07540194006547: Polyaxial Compression Screw, Ø4.5 X 14mm
• 07540194006059: Polyaxial Compression Screw, Ø2.7 X 16mm
• 07540194006042: Varus Plate, Infant 120°
• 07540194006035: Polyaxial Compression Screw, Ø3.5 X 16mm
• 07540194006028: Varus Plate, Child 120°
• 07540194006004: Polyaxial Compression Screw, Ø2.7 X 12mm
• 07540194005991: Polyaxial Compression Screw, Ø3.5 X 12mm
• 07540194005984: Polyaxial Compression Screw, Ø4.5 X 16mm
• 07540194005977: Polyaxial Compression Screw, Ø4.5 X 12mm
• 07540194005960: Varus Plate, Adolescent 120°
• 07540194005953: Varus Plate, HD Adolescent 120°
• 07540194005939: Implant Case -Full
• 07540194005922: Polyaxial Compression Screw, Ø2.7 X 60mm
• 07540194005915: Polyaxial Compression Screw, Ø2.7 X 56mm
• 07540194005908: Polyaxial Compression Screw, Ø2.7 X 52mm
• 07540194005892: Polyaxial Compression Screw, Ø2.7 X 48mm
• 07540194005885: Polyaxial Compression Screw, Ø2.7 X 44mm
• 07540194005878: Polyaxial Compression Screw, Ø2.7 X 40mm
• 07540194005861: Polyaxial Compression Screw, Ø2.7 X 36mm
• 07540194005854: Polyaxial Compression Screw, Ø2.7 X 32mm
• 07540194005847: Polyaxial Compression Screw, Ø2.7 X 28mm
• 07540194005830: Polyaxial Compression Screw, Ø2.7 X 24mm
• 07540194005823: Polyaxial Compression Screw, Ø2.7 X 20mm
• 07540194005816: Locking Screw, Ø2.7 X 40mm
• 07540194005809: Locking Screw, Ø2.7 X 36mm
• 07540194005793: Locking Screw, Ø2.7 X 32mm
• 07540194005786: Locking Screw, Ø2.7 X 28mm
• 07540194005779: Locking Screw, Ø2.7 X 26mm
• 07540194005762: Locking Screw, Ø2.7 X 24mm
• 07540194005755: Locking Screw, Ø2.7 X 22mm
• 07540194005748: Locking Screw, Ø2.7 X 20mm
• 07540194005731: Locking Screw, Ø2.7 X 18mm
• 07540194005724: Locking Screw, Ø2.7 X 16mm
• 07540194005717: Locking Screw, Ø2.7 X 14mm
• 07540194005700: Blade, Infant 35mm
• 07540194005694: Blade, Infant 30mm