Atlas FDA

VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW

FDA 510(k) clearance K140876 · decided 2014-07-22

Clearance details

K-number
K140876
Device name
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
Applicant
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
Decision
Substantially Equivalent
Date received
2014-04-07
Decision date
2014-07-22
Days to decision
106 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Boonton, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a recall (Z-2119-2018)Orthofix, Inc2018-06-07
Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part recall (Z-2120-2018)Orthofix, Inc2018-06-07
Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size ( recall (Z-2121-2018)Orthofix, Inc2018-06-07
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D recall (Z-2122-2018)Orthofix, Inc2018-06-07
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a recall (Z-2123-2018)Orthofix, Inc2018-06-07
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D recall (Z-2124-2018)Orthofix, Inc2018-06-07
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small ( recall (Z-2126-2018)Orthofix, Inc2018-06-07
Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM recall (Z-2127-2018)Orthofix, Inc2018-06-07
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right ( recall (Z-2129-2018)Orthofix, Inc2018-06-07
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) recall (Z-2130-2018)Orthofix, Inc2018-06-07
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small recall (Z-2131-2018)Orthofix, Inc2018-06-07
Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) recall (Z-2132-2018)Orthofix, Inc2018-06-07
TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small ( recall (Z-2133-2018)Orthofix, Inc2018-06-07
T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (0 recall (Z-2134-2018)Orthofix, Inc2018-06-07
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (0 recall (Z-2135-2018)Orthofix, Inc2018-06-07