The following data is part of a premarket notification filed by Orthopedic Designs North America, Inc. with the FDA for Talon Distalfix Proximal Femoral Nail.
Device ID | K111352 |
510k Number | K111352 |
Device Name: | TALON DISTALFIX PROXIMAL FEMORAL NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ORTHOPEDIC DESIGNS NORTH AMERICA, INC. 5912 BRECKENRIDGE PARKWAY SUITE F Tampa, FL 33610 |
Contact | Seth Masek |
Correspondent | Seth Masek ORTHOPEDIC DESIGNS NORTH AMERICA, INC. 5912 BRECKENRIDGE PARKWAY SUITE F Tampa, FL 33610 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-13 |
Decision Date | 2011-08-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B058SLN1550101 | K111352 | 000 |
B058SLN12530L1 | K111352 | 000 |
B058SLN1252201 | K111352 | 000 |
B058SLN1202201 | K111352 | 000 |
B058SLN0111201 | K111352 | 000 |
B058SLN0111151 | K111352 | 000 |
B058SLN0111101 | K111352 | 000 |
B058SLN0111051 | K111352 | 000 |
B058SLN0111001 | K111352 | 000 |
B058SLN0110951 | K111352 | 000 |
B058SLN0110901 | K111352 | 000 |
B058SLN0110851 | K111352 | 000 |
B058SLN0110801 | K111352 | 000 |
B058SLN0110751 | K111352 | 000 |
B058SLN12530R1 | K111352 | 000 |
B058SLN12532L1 | K111352 | 000 |
B058SLN12532R1 | K111352 | 000 |
B058SLN1550051 | K111352 | 000 |
B058SLN1550001 | K111352 | 000 |
B058SLN1302201 | K111352 | 000 |
B058SLN12542R1 | K111352 | 000 |
B058SLN12542L1 | K111352 | 000 |
B058SLN12540R1 | K111352 | 000 |
B058SLN12540L1 | K111352 | 000 |
B058SLN12538R1 | K111352 | 000 |
B058SLN12538L1 | K111352 | 000 |
B058SLN12536R1 | K111352 | 000 |
B058SLN12536L1 | K111352 | 000 |
B058SLN12534R1 | K111352 | 000 |
B058SLN12534L1 | K111352 | 000 |
B058SLN0110701 | K111352 | 000 |