§888.3170. Elbow joint radial (hemi-elbow) polymer prosthesis.
21 C.F.R. § 888.3170
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
Classification. Class II.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.