Biocomposites, Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Biosteon® Screw510(k)Feb 17, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 17, 2026
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer510(k)Jun 12, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 12, 2025
NanoBone® SBX Putty ; NanoBone® QD510(k)Apr 7, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 7, 2025
Genex Bone Graft Substitute510(k)Feb 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 4, 2022