The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip.
Device ID | K133759 |
510k Number | K133759 |
Device Name: | INTELLIJOINT HIP |
Classification | Orthopedic Stereotaxic Instrument |
Applicant | INTELLIJOINT SURGICAL INC. 60 BATHURST DR. Waterloo Ontario, CA N2v 2a9 |
Contact | Brandon Gingrich |
Correspondent | Brandon Gingrich INTELLIJOINT SURGICAL INC. 60 BATHURST DR. Waterloo Ontario, CA N2v 2a9 |
Product Code | OLO |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-11 |
Decision Date | 2014-07-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTELLIJOINT HIP 86198079 4925001 Live/Registered |
Intellijoint Surgical Inc. 2014-02-19 |
INTELLIJOINT HIP 86087964 4777928 Live/Registered |
INTELLIJOINT SURGICAL INC. 2013-10-10 |