Medical Device Manufacturer · US , Philedelphia , PA

Implanet, S.A.

15 submissions · 15 cleared · Since 2012
15
Total
15
Cleared
0
Denied

Implanet, S.A. — FDA 510(k) Submissions

Implanet, S.A. has submitted 15 FDA 510(k) premarket notifications since 2012, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bone Fixation Cerclage, Sublaminar, Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Cervical, Cerclage, Fixation, Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
SQUALE
K230026 · ODP Intervertebral Fusion... · Orthopedic
Mar 2023 83d
Madison Total Knee System
K192084 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2019 81d
JAZZ PF
K191217 · OWI Bone Fixation Cerclage,... · Orthopedic
Aug 2019 88d
ISS-JAZZ Screw System and JAZZ CAP SP
K182771 · NKB Thoracolumbosacral... · Orthopedic
Mar 2019 165d
JAZZ Passer Band
K171881 · OWI Bone Fixation Cerclage,... · Orthopedic
Aug 2017 46d
JAZZ System, including JAZZ Band
K170730 · OWI Bone Fixation Cerclage,... · Orthopedic
Jun 2017 92d
JAZZ FRAME SYSTEM
K162764 · NKB Thoracolumbosacral... · Orthopedic
Jan 2017 111d
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
K160226 · NKB Thoracolumbosacral... · Orthopedic
May 2016 110d
JAZZ LOCK
K153348 · OWI Bone Fixation Cerclage,... · Orthopedic
Mar 2016 132d
JAZZ System
K151740 · OWI Bone Fixation Cerclage,... · Orthopedic
Aug 2015 62d
JAZZ System
K143759 · OWI Bone Fixation Cerclage,... · Orthopedic
May 2015 127d
IMPLANET Spine System (ISS)
K143731 · NKB Thoracolumbosacral... · Orthopedic
Apr 2015 106d
JAZZ SYSTEM
K133617 · OWI Bone Fixation Cerclage,... · Orthopedic
Feb 2014 87d
IMPLANET SPINE SYSTEM
K132303 · OSH Pedicle Screw Spinal... · Orthopedic
Oct 2013 78d
JAZZ SYSTEM
K121541 · JDQ Cerclage, Fixation · Orthopedic
Sep 2012 112d
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