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

Cleared Sep 04, 2026

ActivaScrew™ Cannulated COM

K261057 · HWC

Orthopedic · 157d

Not Cleared Mar 29, 2023

RemeOs™ Screw LAG Solid

DEN220030 · QJD

Orthopedic · 329d

Cleared Jan 22, 2014

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

K133950 · HTY

Orthopedic · 30d

Cleared Aug 28, 2013

BIORETEC ACTIVASCREW INTERFERENCE

K130716 · MAI

Orthopedic · 166d

Cleared Jun 24, 2008

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION,...

K080879 · HTY

Orthopedic · 85d

Cleared Jun 18, 2008

BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH...

K081392 · HWC

Orthopedic · 30d

Cleared Nov 02, 2007

ACTIVASCREW

K072848 · HWC

Orthopedic · 29d

Cleared Aug 31, 2007

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

K071863 · HTY

Orthopedic · 56d

Cleared Nov 22, 2006

ACTIVASCREW

K062980 · HWC

Orthopedic · 54d

Cleared Jul 06, 2006

ACTIVAPIN

K061164 · HTY

Orthopedic · 71d