The following data is part of a premarket notification filed by John Riccio with the FDA for Fusion Medical Cannulated Screw System.
Device ID | K081122 |
510k Number | K081122 |
Device Name: | FUSION MEDICAL CANNULATED SCREW SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | JOHN RICCIO 1663 SOUTH MAIN STREET Waterbury, CT 06706 |
Contact | John Riccio |
Correspondent | John Riccio JOHN RICCIO 1663 SOUTH MAIN STREET Waterbury, CT 06706 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-21 |
Decision Date | 2009-05-26 |
Summary: | summary |