The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-IB-45

GUDID 07540194013156

BLADE, INFANT 45mm

Pega Medical Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID07540194013156
NIH Device Record Key30359d22-8253-473b-8ab8-a7bdd8fb54cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Locking Pediatric Osteotomy Plate (LolliPOP) System
Version Model NumberPOP-IB-45
Catalog NumberPOP-IB-45
Company DUNS257315713
Company NamePega Medical Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194013156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


[07540194013156]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-22
Device Publish Date2021-04-14

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

07540194006707M4 Connector For Child
07540194006691M3 Connector For Infant
07540194008824FULL LOLLIPOP INFANT/CHILD SCREW CADDY
07540194008817FULL LOLLIPOP ADO/HD SCREW CADDY
07540194008800FULL LOLLIPOP INFANT/CHILD IMPLANT CASE
07540194008794FULL LOLLIPOP ADO/HD IMPLANT CASE
07540194008787CONNECTOR FOR ADOLESCENT & HD ADOLESCENT
07540194010919LOLLIPOP DEROTATION PIN Ø2.8 - PACKAGE OF 2
07540194010902LOLLIPOP GUIDE WIRE Ø2.0mm - PACKAGE OF 6
07540194010926LOLLIPOP DEROTATION PIN Ø2.8 - PACKAGE OF 6
07540194010896LOLLIPOP GUIDE WIRE Ø2.0mm - PACKAGE OF 2
07540194009388LOLLIPOP INSTRUMENT CASE ADO/ADO HD RENTAL
07540194009371LOLLIPOP INSTRUMENT CASE INFANT/CHILD RENTAL
07540194009357WIRE GUIDE
07540194009340VERBRUGGE INFANT
07540194009333VERBRUGGE CHILD
07540194009326VERBRUGGE ADO/ADO HD
07540194009319POSITIONING TRIANGLE, 110-60-10°
07540194009302POSITIONING TRIANGLE, 100-60-20°
07540194009296POSITIONING TRIANGLE, 90-50-40°
07540194009289POSITIONING TRIANGLE, 80-70-30°
07540194009272ADO/ADO HD LOCKING SLEEVE, Ø4.5mm
07540194009265CHILD LOCKING SLEEVE, Ø3.5mm
07540194009258INFANT LOCKING SLEEVE, Ø2.7mm
07540194009241SLAP HAMMER
07540194009234CONNECTOR SHAFT, ADO/ADO HD
07540194009227CONNECTOR SHAFT, CHILD
07540194009210CONNECTOR SHAFT, INFANT
07540194009203OSTEOTOMY GUIDE, VALGUS ADO HD
07540194009197OSTEOTOMY GUIDE, VALGUS ADO
07540194009180OSTEOTOMY GUIDE, VALGUS CHILD
07540194009173OSTEOTOMY GUIDE, VALGUS INFANT
07540194009166DRILL GUIDE FOR ADO Ø4.5mm SCREWS
07540194009159DRILL GUIDE FOR CHILD Ø3.5mm SCREWS
07540194009142DRILL GUIDE FOR INFANT Ø2.7mm SCREWS
07540194009135BLADE JOYSTICK, ADO/ADO HD
07540194009128BLADE JOYSTICK, CHILD
07540194009111BLADE JOYSTICK, INFANT
07540194009104FULL LOLLIPOP INFANT/CHILD INSTRUMENT CASE
07540194009098FULL LOLLIPOP ADO/ADO HD INSTRUMENT CASE
07540194009081EMPTY LOLLIPOP INFANT/CHILD INSTRUMENT CASE
07540194009074EMPTY LOLLIPOP ADO/ADO HD INSTRUMENT CASE
07540194009067IMPACTION DRIVER
07540194009050EMPTY LOLLIPOP INFANT/CHILD IMPLANT CASE
07540194009043EMPTY LOLLIPOP ADO/ADO HD IMPLANT CASE
07540194009036HANDLE
07540194009029LOLLIPOP DEROTATION PIN Ø2.8
07540194009012LOLLIPOP GUIDE WIRE Ø2.0 x 254mm
07540194009005FLEXION-EXTENSION GUIDE
07540194008992DEROTATION GUIDE

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