FDA.reportPublic FDA data

Maxillofacial bone separator

Definition
A hand-held, manual, one-piece surgical instrument intended to split/force apart bones in the face, mouth and/or jaws (e.g., palate, mandibular inferior border) during maxillofacial surgery (e.g., sagittal split osteotomy procedure); it is not designed to cut or shape bone (i.e., not an osteotome). It is a metal instrument typically available as: 1) a curved shaft with a handle and a blade at the distal working end; or 2) a hinged device with two blades at the distal working end and a spring handle. This is a reusable device.
GUDID devices
29
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
D894BE010rexpanderRex Implants, Inc.1.6 x 92022-12-30
D894BE020rexpanderRex Implants, Inc.1.6 x 112022-12-30
D894BE030rexpanderRex Implants, Inc.1.6 x 132022-12-30
D894BE040rexpanderRex Implants, Inc.1.6 x 152022-12-30
D894BE050rexpanderRex Implants, Inc.2.0 x 92022-12-30
D894BE060rexpanderRex Implants, Inc.2.0 x 112022-12-30
D894BE070rexpanderRex Implants, Inc.2.0 x 132022-12-30
D894BE080rexpanderRex Implants, Inc.2.0 x 152022-12-30
D894BE090rexpanderRex Implants, Inc.2.4 x 92022-12-30
D894BE100rexpanderRex Implants, Inc.2.4 x 112022-12-30
D894BE110rexpanderRex Implants, Inc.2.4 x 132022-12-30
D894BE120rexpanderRex Implants, Inc.2.4 x 152022-12-30
D894BE130rexpanderRex Implants, Inc.2.8 x 92022-12-30
D894BE140rexpanderRex Implants, Inc.2.8 x 112022-12-30
D894BE150rexpanderRex Implants, Inc.2.8 x 132022-12-30
D894BE160rexpanderRex Implants, Inc.2.8 x 152022-12-30
D894BE170rexpanderRex Implants, Inc.3.2 x 92022-12-30
D894BE180rexpanderRex Implants, Inc.3.2 x 112022-12-30
D894BE190rexpanderRex Implants, Inc.3.2 x 132022-12-30
D894BE200rexpanderRex Implants, Inc.3.2 x 152022-12-30
D894BE210rexpanderRex Implants, Inc.3.6 x 92022-12-30
D894BE220rexpanderRex Implants, Inc.3.6 x 112022-12-30
D894BE230rexpanderRex Implants, Inc.3.6 x 132022-12-30
D894BE240rexpanderRex Implants, Inc.3.6 x 152022-12-30
00810158212589PRINCETONPrinceton Medical Group, Inc.49695-022024-07-24
00810158212596PRINCETONPrinceton Medical Group, Inc.49670-202024-07-24
10885403067006V. MuellerSTERIS CORPORATIONMO96502018-09-05
10885403067013V. MuellerSTERIS CORPORATIONMO96552018-09-05
10885403067051V. MuellerSTERIS CORPORATIONMO96602018-09-05