FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
12457–12480 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · HRS
Biomet, Inc.
Orthopedic · 251d
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897 · MQV
Synthes (Usa)
Orthopedic · 185d
Cleared Dec 20, 2001
SIGN IM NAIL
K013132 · HSB
Surgical Implant Generation Network...
Orthopedic · 92d
Cleared Dec 20, 2001
RT-PLUS KNEE ADDITIONAL COMPONENTS
K013340 · KRO
Plus Orthopedics
Orthopedic · 72d
Cleared Dec 20, 2001
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
K013424 · HTY
Hand Innovations, Inc.
Orthopedic · 66d
Cleared Dec 20, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · LPH
Howmedica Osteonics Corp.
Orthopedic · 62d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Dec 19, 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
K013449 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · MBI
Linvatec Corp.
Orthopedic · 55d
Cleared Dec 19, 2001
POLARUS CAP SCREW
K013616 · HSB
Acu Med, Inc.
Orthopedic · 44d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · KWP
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Dec 19, 2001
CODMAN SLIM-LOC SYSTEM
K013877 · KWQ
Codman & Shurtleff, Inc.
Orthopedic · 26d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Dec 19, 2001
GENERATION 4 BONE CEMENT
K993836 · LOD
Biomet, Inc.
Orthopedic · 768d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Dec 17, 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d
Cleared Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
K013534 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 55d
Cleared Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
K013786 · HWC
Doctor'S Research Group, Inc.
Orthopedic · 33d
Cleared Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
K013903 · HWC
Triad Medical, Inc.
Orthopedic · 21d
Cleared Dec 13, 2001
SPINE SCOPE, MODEL 2180
K011454 · HRX
Clarus Medical, LLC
Orthopedic · 216d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · MBI
Arthocare Corporation
Orthopedic · 65d
Cleared Dec 13, 2001
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739 · LXT
Ebi, L.P.
Orthopedic · 30d