ANSER Clavicle Pin – FDA Approval
Message from the FDA
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.
Congrats to all who contributed to the realization of the product, the instruments and the file!
The ANSER Clavicle pin received FDA approval. BAAT Medical is Legal Manufacturer.
