The following data is part of a premarket notification filed by Orthovestments, Llc with the FDA for Orbitum Bone Staple Implant, X And Vi.
Device ID | K173693 |
510k Number | K173693 |
Device Name: | Orbitum Bone Staple Implant, X And VI |
Classification | Staple, Fixation, Bone |
Applicant | Orthovestments, LLC 1640 Powers Ferry Bldg 9 Marietta, GA 30067 |
Contact | Robert Weinstein |
Correspondent | Robert Weinstein Orthovestments, LLC 1640 Powers Ferry Bldg 9 Marietta, GA 30067 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-01 |
Decision Date | 2018-02-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B565FO2021241 | K173693 | 000 |
B565FO2007201 | K173693 | 000 |
B565FO20140961 | K173693 | 000 |
B565FO20141161 | K173693 | 000 |
B565FO20141661 | K173693 | 000 |
B565FO20142061 | K173693 | 000 |
B565FO20142091 | K173693 | 000 |
B565FO20130960 | K173693 | 000 |
B565FO20131160 | K173693 | 000 |
B565FO2007161 | K173693 | 000 |
B565FO2007121 | K173693 | 000 |
B565FO2020201 | K173693 | 000 |
B565FO100124140 | K173693 | 000 |
B565FO100024140 | K173693 | 000 |
B565FO100024160 | K173693 | 000 |
B565FO20211201 | K173693 | 000 |
B565FO20211601 | K173693 | 000 |
B565FO20212001 | K173693 | 000 |
B565FO2020121 | K173693 | 000 |
B565FO2020161 | K173693 | 000 |
B565FO20131660 | K173693 | 000 |
B565FO20132060 | K173693 | 000 |
B565FO2004200 | K173693 | 000 |
B565FO20060 | K173693 | 000 |
B565FO20150 | K173693 | 000 |
B565FO100012080 | K173693 | 000 |
B565FO100016100 | K173693 | 000 |
B565FO100020120 | K173693 | 000 |
B565FO100112080 | K173693 | 000 |
B565FO100116100 | K173693 | 000 |
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B565FO2004120 | K173693 | 000 |
B565FO20030 | K173693 | 000 |
B565FO20160960 | K173693 | 000 |
B565FO20161160 | K173693 | 000 |
B565FO20161660 | K173693 | 000 |
B565FO20162060 | K173693 | 000 |
B565FO20010 | K173693 | 000 |
B565FO2002120 | K173693 | 000 |
B565FO2002160 | K173693 | 000 |
B565FO2002200 | K173693 | 000 |
B565FO100120120 | K173693 | 000 |