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 |
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| B565FO20142091 | K173693 | 000 |
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| B565FO20131160 | K173693 | 000 |
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| B565FO100120120 | K173693 | 000 |