The following data is part of a premarket notification filed by Navbit Pty Ltd with the FDA for Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration.
| Device ID | K200376 |
| 510k Number | K200376 |
| Device Name: | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Navbit Pty Ltd Suite 1A, 136 Willoughby Road Crows Nest, AU 2065 |
| Contact | David Thomson |
| Correspondent | Elizabeth O'keeffe 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 | 2020-02-18 |
| Decision Date | 2020-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09369998142903 | K200376 | 000 |