Device typeOrthopaedic fixation plate, bioabsorbable: A non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
FDA categoryPlate, Fixation, Bone, Non-Spinal, Metallic
Device ID00840124513730
Catalog numberSB-TB-1000
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information