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
8593–8616 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 05, 2010
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
K093868 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 231d
Cleared Aug 05, 2010
WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM
K100820 · MAX
Wenzel Spine
Orthopedic · 135d
Cleared Aug 05, 2010
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952 · NKB
Synthes Spine
Orthopedic · 121d
Cleared Aug 04, 2010
ORTHOMAP 3D 1.1 MODULE
K093206 · OLO
Stryker Corp.
Orthopedic · 295d
Cleared Aug 03, 2010
ALIGN RADIAL HEAD SYSTEM
K092721 · KWI
Skeletal Dynamics, LLC
Orthopedic · 333d
Cleared Aug 03, 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · HRS
Synthes (Usa)
Orthopedic · 138d
Cleared Aug 02, 2010
ASCENSION TOTAL PLATE SYSTEM
K100502 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 161d
Cleared Aug 02, 2010
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS...
K100741 · PHX
Encore Medical, L.P.
Orthopedic · 139d
Cleared Aug 02, 2010
RANGE SPINAL SYSTEM
K100851 · MNI
K2m, Inc.
Orthopedic · 129d
Cleared Aug 02, 2010
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
K101909 · PHX
Exactech, Inc.
Orthopedic · 25d
Cleared Aug 02, 2010
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
K101981 · JWH
Exactech, Inc.
Orthopedic · 19d
Cleared Jul 30, 2010
VEGA KNEE SYSTEM
K101281 · JWH
Aesculap Implant System, Inc.
Orthopedic · 85d
Cleared Jul 30, 2010
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM...
K101296 · LZO
Zimmer, Inc.
Orthopedic · 81d
Cleared Jul 29, 2010
BIOGENNIX RPC
K093342 · MQV
Biogennix, LLC
Orthopedic · 276d
Cleared Jul 29, 2010
ENDOSKELETON TC
K100889 · ODP
Titan Spine, LLC
Orthopedic · 120d
Cleared Jul 28, 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926 · NKB
Blackstone Medical, Inc.
Orthopedic · 218d
Cleared Jul 28, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678 · MNH
Spineart
Orthopedic · 43d
Cleared Jul 23, 2010
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
K100147 · NKB
Aesculap Implant System, Inc.
Orthopedic · 185d
Cleared Jul 23, 2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
K101165 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Jul 23, 2010
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
K101206 · HSX
Alexandria Research Technologies, LLC
Orthopedic · 84d
Cleared Jul 23, 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 80d
Cleared Jul 22, 2010
IMPIX LUMBAR INTERBODY DEVICE
K100544 · MAX
Medicrea Technologies
Orthopedic · 147d
Cleared Jul 22, 2010
VENUS BASIC SPINAL FIXATION SYSTEM
K100706 · MNH
L & K Biomed Co., Ltd.
Orthopedic · 132d
Cleared Jul 22, 2010
ALEUTIAN IBF SYSTEM
K101302 · ODP
K2m, Inc.
Orthopedic · 73d