The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip System (cart), Intellijoint Hip System (portable), Intellijoint Hip Instrument Tray.
Device ID | K172849 |
510k Number | K172849 |
Device Name: | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray |
Classification | Orthopedic Stereotaxic Instrument |
Applicant | Intellijoint Surgical Inc. 60 Bathurst Drive Unit 6 Waterloo, CA N2v 2a9 |
Contact | Brandon Gingrich |
Correspondent | Brandon Gingrich Intellijoint Surgical Inc. 60 Bathurst Drive Unit 6 Waterloo, CA N2v 2a9 |
Product Code | OLO |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-20 |
Decision Date | 2017-11-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00628184003732 | K172849 | 000 |
00628184003763 | K172849 | 000 |
00628184003770 | K172849 | 000 |
00628184002827 | K172849 | 000 |
00628184002834 | K172849 | 000 |
00628184002841 | K172849 | 000 |
00628184002858 | K172849 | 000 |
00628184003664 | K172849 | 000 |
00628184003688 | K172849 | 000 |
00628184003862 | K172849 | 000 |