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FDA 510(k)

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component

K-Number: K183025 · 2019-01-28

Decision Date2019-01-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is a medical device manufactured by B-One Ortho, Corp.. It received FDA 510(k) clearance on 2019-01-28 under approval number K183025. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is a medical device that received FDA 510(k) clearance on 2019-01-28. It is manufactured by B-One Ortho, Corp.. The 510(k) number is K183025.

When was MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component approved by the FDA?

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component received FDA 510(k) clearance on 2019-01-28, under approval number K183025.

What company makes MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is manufactured by B-One Ortho, Corp..

What is the FDA product code for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

The FDA product code for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is JWH.

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Official Source

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