Biocomposites, Ltd. - FDA 510(k) Cleared Devices

Cleared Feb 17, 2026

Biosteon® Screw

K251680 · MAI

Orthopedic · 263d

Cleared Jun 12, 2025

Synicem Hip Spacer

K242865 · KWL

Orthopedic · 265d

Cleared Apr 07, 2025

NanoBone® SBX Putty

K250521 · MQV

Orthopedic · 45d

Cleared Feb 04, 2022

Genex Bone Graft Substitute

K212721 · MQV

Orthopedic · 161d

Cleared Jan 23, 2015

STIMULAN KIT, STIMULAN RAPID CURE

K141830 · MQV

Orthopedic · 200d

Cleared Nov 14, 2008

GENEX

K082381 · MQV

Orthopedic · 87d

Cleared Jul 09, 2008

GENEX PUTTY

K073341 · MQV

Orthopedic · 224d

Cleared Jun 20, 2008

MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR

K081428 · HWC

Orthopedic · 30d

Cleared Aug 31, 2007

DOMINATOR

K072127 · HWC

Orthopedic · 29d

Cleared Aug 14, 2007

GRAFTLOCK SCREW, ST SCREW

K071952 · HWC

Orthopedic · 29d

Cleared May 17, 2007

MODIFICATION TO BILOK SCREW

K071091 · HWC

Orthopedic · 29d

Cleared May 17, 2007

MODIFICATION TO BILOK ST SCREW

K071115 · HWC

Orthopedic · 27d