Tag: IDE

Seven-year IDE trial results show “prolonged and significant improvements” of activL...

Aesculap Implant Systems has announced the publication of seven-year results from a randomised controlled investigational device exemption (IDE) trial for lumbar artificial discs in...

ISASS 2021: Positive results out to four years reported for M6-C...

Orthofix Medical has announced preliminary three- and four-year functional outcomes from the M6-C artificial cervical disc single-level investigational device exemption (IDE) study which has shown that the...

Cerapedics granted breakthrough device designation for P-15L bone graft

Cerapedics has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its investigational P-15L bone...

Cerapedics receives FDA approval to initiate IDE study of P-15L bone...

Cerapedics, a privately-held orthobiologics company, has announced the company received approval from the US Food and Drug Administration (FDA) to initiate an investigational device...

US FDA approves IDE study for Premia Spine’s Tops system

Premia Spine has secured US Food and Drug Administration approval for its pivotal study of the new Tops system.  “We are excited about the opportunity to...