The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip Generation 2a System.
Device ID | K162364 |
510k Number | K162364 |
Device Name: | Intellijoint HIP Generation 2A System |
Classification | Orthopedic Stereotaxic Instrument |
Applicant | INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 6 Waterloo, CA N2v 2a9 |
Contact | Brandon Gingrich |
Correspondent | Brandon Gingrich INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 6 Waterloo, 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 | 2016-08-23 |
Decision Date | 2017-03-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00628184003589 | K162364 | 000 |
00628184003565 | K162364 | 000 |
00628184003008 | K162364 | 000 |
00628184002803 | K162364 | 000 |
00628184002759 | K162364 | 000 |