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FDA 510(k)

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

K-Number: K200376 · 2020-12-10

ApplicantNavbit Pty, Ltd.
Decision Date2020-12-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration is a medical device manufactured by Navbit Pty, Ltd.. It received FDA 510(k) clearance on 2020-12-10 under approval number K200376. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration?

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by Navbit Pty, Ltd.. The 510(k) number is K200376.

When was Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration approved by the FDA?

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration received FDA 510(k) clearance on 2020-12-10, under approval number K200376.

What company makes Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration?

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration is manufactured by Navbit Pty, Ltd..

What is the FDA product code for Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration?

The FDA product code for Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration is OLO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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