510(k) K160995 ยท HRS Plate, Fixation, Bone
NEOVIEW Plating System
| Applicant | In2bones Sas, Ecully, FR |
| Decision | Substantially Equivalent, Jun 10, 2016 |
| Received | Apr 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160995
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2017 | In2Bones, SAS Non-Locking screws in the following lengths:
(a) NEO(R) 0.27 - 10 mm, REF W27 ST010
(b) NEO(R) 0.27 - 12 mm, REF W27 ST012
(c) DRP 0.27 - 12 mm, REF W27 ST012
(d) NEO(R) 0.27 - 14 mm, REF W27 ST01 Terminated |
HRS | None listed |
| Jan 6, 2017 | In2Bones, SAS SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France
The NEOVIEW Plating System is intended for fixation of intra-articular and extraartic Terminated |
HRS | None listed |
| Jan 6, 2017 | In2Bones, SAS NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France
The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fracture Terminated |
HRS | None listed |
| Jan 6, 2017 | In2Bones, SAS NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R
The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the dist Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.