ClearanceBrief
510(k) K060038 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented

SBI RADIO-CAPITELLAR IMPLANT

ApplicantSmall Bone Innovations, Inc., New York NY, US
DecisionSubstantially Equivalent, Mar 30, 2006
ReceivedJan 6, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060038

DateFirm and productCodeLinked 510(k)
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed
Oct 24, 2017Howmedica Osteonics Corp.
Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Terminated
JDBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.