SpaceFlex Shoulder
K-Number: K202338 · 2021-02-17
ApplicantG21, S.R.L.
Decision Date2021-02-17
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SpaceFlex Shoulder is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2021-02-17 under approval number K202338. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SpaceFlex Shoulder?
SpaceFlex Shoulder is a medical device that received FDA 510(k) clearance on 2021-02-17. It is manufactured by G21, S.R.L.. The 510(k) number is K202338.
When was SpaceFlex Shoulder approved by the FDA?
SpaceFlex Shoulder received FDA 510(k) clearance on 2021-02-17, under approval number K202338.
What company makes SpaceFlex Shoulder?
SpaceFlex Shoulder is manufactured by G21, S.R.L..
What is the FDA product code for SpaceFlex Shoulder?
The FDA product code for SpaceFlex Shoulder is MBB.
Other Devices by G21, S.R.L.
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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.