Device type
Screw, Fixation, Bone
Product code HWC · Class II · 21 CFR 888.3040 · Orthopedic
Recent 510(k)s
Oct 14, 2026
K261961
Ntegrate Threaded Nail System
Nvision Biomedical Technologies
- HWC
- Class II
Oct 2, 2026
K263116
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
OsteoCentric Technologies
- HWC
- Class II
Sep 25, 2026
K262975
Arthrex Beaming System
Arthrex, Inc.
- HWC
- Class II
Sep 23, 2026
K260995
DynaNail Helix® Fixation System
MedShape, Inc.
- HWC
- Class II
Sep 21, 2026
K254280
F.A.S.T Screw
Steps Ortho
- HWC
- Class II
Sep 4, 2026
K261057
ActivaScrew™ Cannulated COM
Bioretec, Ltd.
- HWC
- Class II
Aug 24, 2026
K260106
OsteoCoil™ GT Active Compression System
Flower Orthopedics Corporation DBA Conventus Flower Orthoped
- HWC
- Class II
Recent recalls
Oct 21, 2026
Z-0157-2027
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
In2bones USA, LLC
- HWC
- Class II
- Ongoing