Bioretec, Ltd. is one of 47 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Bioretec, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ActivaScrew™ Cannulated COM, ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.), BIORETEC ACTIVASCREW INTERFERENCE
10
Total
9
Cleared
1
Denied
Bioretec, Ltd. has 9 FDA 510(k) cleared orthopedic devices. Based in Tampere, FI.
Latest FDA clearance: Sep 2026. Active since 2006.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Compliance Solutions (Life Sciences) , Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Bioretec, Ltd.
10 devices
Cleared
Sep 04, 2026
ActivaScrew™ Cannulated COM
Orthopedic
157d
Not Cleared
Mar 29, 2023
RemeOs™ Screw LAG Solid
Orthopedic
329d
Cleared
Jan 22, 2014
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
Orthopedic
30d
Cleared
Aug 28, 2013
BIORETEC ACTIVASCREW INTERFERENCE
Orthopedic
166d
Cleared
Jun 24, 2008
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION,...
Orthopedic
85d
Cleared
Jun 18, 2008
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH...
Orthopedic
30d
Cleared
Nov 02, 2007
ACTIVASCREW
Orthopedic
29d
Cleared
Aug 31, 2007
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)
Orthopedic
56d
Cleared
Nov 22, 2006
ACTIVASCREW
Orthopedic
54d
Cleared
Jul 06, 2006
ACTIVAPIN
Orthopedic
71d