GMReis Fibula Nail System
K-Number: K250559 · 2025-06-12
ApplicantGm Dos Reis Industria E Comercio
Decision Date2025-06-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GMReis Fibula Nail System is a medical device manufactured by Gm Dos Reis Industria E Comercio. It received FDA 510(k) clearance on 2025-06-12 under approval number K250559. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GMReis Fibula Nail System?
GMReis Fibula Nail System is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Gm Dos Reis Industria E Comercio. The 510(k) number is K250559.
When was GMReis Fibula Nail System approved by the FDA?
GMReis Fibula Nail System received FDA 510(k) clearance on 2025-06-12, under approval number K250559.
What company makes GMReis Fibula Nail System?
GMReis Fibula Nail System is manufactured by Gm Dos Reis Industria E Comercio.
What is the FDA product code for GMReis Fibula Nail System?
The FDA product code for GMReis Fibula Nail System is HSB.
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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.