Atlas FDA

PEDINAIL INTRAMEDULLARY NAILING SYSTEM

FDA 510(k) clearance K083726 · decided 2009-03-11

Clearance details

K-number
K083726
Device name
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
Applicant
OrthoPediatrics Corp.
Decision
Substantially Equivalent
Date received
2008-12-15
Decision date
2009-03-11
Days to decision
86 days
Clearance type
Traditional
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw recall (Z-0879-2017)OrthoPediatrics Corp2016-12-22
Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0339-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-034-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0341-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0342-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN; P recall (Z-0343-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0344-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0345-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0346-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0347-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0348-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0349-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0350-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0351-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0352-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0353-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0354-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0355-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0356-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0357-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0358-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0359-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0360-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0361-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0362-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0363-2010)Orthopediatrics Corp2010-05-12
Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, I recall (Z-0364-2010)Orthopediatrics Corp2010-05-12