The Locking Pediatric Osteotomy Plate (LolliPOP) S POP-OB45-22

GUDID 07540194006561

Polyaxial Compression Screw, Ø4.5 X 22mm

Pega Medical Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID07540194006561
NIH Device Record Key17ff1852-a626-467c-8100-821d50aa32fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Locking Pediatric Osteotomy Plate (LolliPOP) S
Version Model NumberPOP-OB45-22
Catalog NumberPOP-OB45-22
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

Device Dimensions

Outer Diameter4.5 Millimeter
Length22 Millimeter
Outer Diameter4.5 Millimeter
Length22 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194006561 [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

[07540194006561]

Moist Heat or Steam Sterilization

[07540194006561]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-25
Device Publish Date2019-01-25

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

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