A fixation device for the fixation of bone fragments, applicable to the mutual fastening of bone fragments temporarily separated during a surgical operation or as a result of a trauma. The device is also suitable for the fixation of a bone flap in the replacement thereof in a corresponding aperture made in the cranium or cranial bone mass. The device is made of biocompatible material and has a flexible strip and fastening mechanism, the strip having a length allowing the formation of a fastening loop tightly fastening the bone fragments to be joined together. The fastening mechanism is provided with at least one opening provided with an interlocking mechanism allowing the passage of a free end of the strip and preventing its extraction in the direction opposite to the insertion.