The following data is part of a premarket notification filed by Degen Medical with the FDA for Degen Navigated Instrumentation.
| Device ID | K203816 |
| 510k Number | K203816 |
| Device Name: | DeGen Navigated Instrumentation |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | DeGen Medical 1321-C North Cashua Drive Florence, SC 29501 |
| Contact | Craig Black |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-29 |
| Decision Date | 2021-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842048138860 | K203816 | 000 |
| 00842048138853 | K203816 | 000 |
| 00842048138846 | K203816 | 000 |
| 00842048138839 | K203816 | 000 |
| 00842048138822 | K203816 | 000 |