II-Type Intervertebral Spacer
K-Number: K180228 · 2019-01-11
ApplicantPaonan Biotech Co., Ltd.
Decision Date2019-01-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
II-Type Intervertebral Spacer is a medical device manufactured by Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-01-11 under approval number K180228. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the II-Type Intervertebral Spacer?
II-Type Intervertebral Spacer is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Paonan Biotech Co., Ltd.. The 510(k) number is K180228.
When was II-Type Intervertebral Spacer approved by the FDA?
II-Type Intervertebral Spacer received FDA 510(k) clearance on 2019-01-11, under approval number K180228.
What company makes II-Type Intervertebral Spacer?
II-Type Intervertebral Spacer is manufactured by Paonan Biotech Co., Ltd..
What is the FDA product code for II-Type Intervertebral Spacer?
The FDA product code for II-Type Intervertebral Spacer is MAX.
Other Devices by Paonan Biotech Co., Ltd.
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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.