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
8257–8280 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 24, 2011
GMK REVISION KNEE SC LINERS
K103170 · JWH
Medacta International S.A.
Orthopedic · 148d
Cleared Mar 24, 2011
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
K103837 · JWH
Ortho Development
Orthopedic · 84d
Cleared Mar 24, 2011
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
K110054 · OLO
Zimmer Cas
Orthopedic · 76d
Cleared Mar 24, 2011
ARCOMXL ACTIVE ARTICULATION
K110555 · LPH
Biomet Manufacturing Corp
Orthopedic · 24d
Cleared Mar 23, 2011
FORZA SPACER SYSTEM
K103111 · MAX
Orthofix, Inc.
Orthopedic · 153d
Cleared Mar 23, 2011
LANX LATERAL
K103666 · MAX
Lanx, Inc.
Orthopedic · 98d
Cleared Mar 23, 2011
PIONEER SPINAL PROCESS FUSION PLATE
K110367 · KWP
Pioneer Surgical Technology, Inc.
Orthopedic · 43d
Cleared Mar 23, 2011
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
K110512 · OUR
Zyga Technology, Inc.
Orthopedic · 28d
Cleared Mar 23, 2011
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
K110552 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Mar 22, 2011
JTS EXTENDEABLE IMPLANT
K092138 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 615d
Cleared Mar 22, 2011
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
K093046 · ONN
Synvasive Technology, Inc.
Orthopedic · 538d
Cleared Mar 21, 2011
MPACT ACETABULAR SYSTEM
K103721 · LPH
Medacta International
Orthopedic · 90d
Cleared Mar 18, 2011
LOW PROFILE SCREWS
K103705 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 18, 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476 · HRS
Stryker Corp.
Orthopedic · 28d
Cleared Mar 17, 2011
REVERE SACRAL PLATES
K103072 · NKB
Globus Medical, Inc.
Orthopedic · 150d
Cleared Mar 17, 2011
EVEREST SPINAL SYSTEM
K103440 · MNI
K2m, Inc.
Orthopedic · 114d
Cleared Mar 17, 2011
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742 · MBP
Integra Life Sciences
Orthopedic · 84d
Cleared Mar 17, 2011
CONCORDE CURVE SYSTEM
K103743 · MAX
Johnson & Johnson
Orthopedic · 84d
Cleared Mar 17, 2011
PEZO INTERBODY CAGES SYSTEM
K103814 · MAX
Ulrich GmbH & Co. KG
Orthopedic · 78d
Cleared Mar 17, 2011
FLEXFUSION (TM) FIXATION IMPLANT
K110445 · HWC
Nextremity Solutions, LLC
Orthopedic · 29d
Cleared Mar 16, 2011
AAXTER A3 POSTERIOR SPINAL SYSTEM
K101374 · MNH
Aaxter Co., Ltd.
Orthopedic · 303d
Cleared Mar 16, 2011
ESCALADE ACETABULAR CUP SYSTEM
K103384 · LPH
Ortho Development
Orthopedic · 118d
Cleared Mar 15, 2011
MEMOMETAL NAVIS BONE PLATING SYSTEM
K101930 · HRS
Memometal Technologies
Orthopedic · 249d
Cleared Mar 15, 2011
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
K103404 · KWT
Zimmer GmbH
Orthopedic · 116d