Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SINEFIX

K-Number: K254176 · 2026-03-16

ApplicantBAAT Medical Products B.V.
Decision Date2026-03-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINEFIX is a medical device manufactured by BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2026-03-16 under approval number K254176. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINEFIX?

SINEFIX is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by BAAT Medical Products B.V.. The 510(k) number is K254176.

When was SINEFIX approved by the FDA?

SINEFIX received FDA 510(k) clearance on 2026-03-16, under approval number K254176.

What company makes SINEFIX?

SINEFIX is manufactured by BAAT Medical Products B.V..

What is the FDA product code for SINEFIX?

The FDA product code for SINEFIX is MBI.

Other Devices by BAAT Medical Products B.V.

K201830ANSER Clavicle Pin K211474Kleiner KG2 System K220966SINEFIX K251961SDS Growing Rod

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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.

↑