REGEN Bioactive Cement
K-Number: K253337 · 2026-04-15
ApplicantInter-Med, Inc.
Decision Date2026-04-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
REGEN Bioactive Cement is a medical device manufactured by Inter-Med, Inc.. It received FDA 510(k) clearance on 2026-04-15 under approval number K253337. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the REGEN Bioactive Cement?
REGEN Bioactive Cement is a medical device that received FDA 510(k) clearance on 2026-04-15. It is manufactured by Inter-Med, Inc.. The 510(k) number is K253337.
When was REGEN Bioactive Cement approved by the FDA?
REGEN Bioactive Cement received FDA 510(k) clearance on 2026-04-15, under approval number K253337.
What company makes REGEN Bioactive Cement?
REGEN Bioactive Cement is manufactured by Inter-Med, Inc..
What is the FDA product code for REGEN Bioactive Cement?
The FDA product code for REGEN Bioactive Cement is EMA.
Related Clinical Trials
Other Devices by Inter-Med, Inc.
Related Devices (Code: EMA)
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.