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
6625–6648 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 25, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC...
K133162 · JWH
Materialise NV
Orthopedic · 131d
Cleared Feb 25, 2014
PRESSON SPINAL FIXATION SYSTEM
K133287 · MNH
Nexus Spine, LLC
Orthopedic · 123d
Cleared Feb 25, 2014
CD HORIZON SPINAL SYSTEM GROWTH ROD SET
K133904 · PGM
Medtronic Sofamor Danek USA
Orthopedic · 67d
Cleared Feb 24, 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · HRS
Osteomed LP
Orthopedic · 84d
Cleared Feb 21, 2014
FREEDOM PCK COMPONENTS
K131481 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 275d
Cleared Feb 21, 2014
NOVOHIP TOTAL HIP SYSTEM
K132158 · LPH
Novosource, Inc.
Orthopedic · 224d
Cleared Feb 20, 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567 · KWQ
Globus Medical, Inc.
Orthopedic · 92d
Cleared Feb 20, 2014
INBONE TOTAL ANKLE
K133585 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 91d
Cleared Feb 20, 2014
JAZZ SYSTEM
K133617 · OWI
Implanet, S.A.
Orthopedic · 87d
Cleared Feb 19, 2014
MODIFICATION TO NAUTILUS SPINAL SYSTEM
K133564 · NKB
Life Spine, LLC
Orthopedic · 91d
Cleared Feb 18, 2014
KASM KNEE ARTICULATING SPACER MOLDS
K133449 · JWH
Ortho Development Corp.
Orthopedic · 98d
Cleared Feb 12, 2014
KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
K131454 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 268d
Cleared Feb 12, 2014
CONVENTUS DRS
K131552 · HRS
Conventus Orthopaedics
Orthopedic · 258d
Cleared Feb 12, 2014
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K132582 · OVE
Exactech, Inc.
Orthopedic · 180d
Cleared Feb 12, 2014
C-BOX PEEK CERVICAL IBF
K132991 · ODP
Innovasis, Inc.
Orthopedic · 141d
Cleared Feb 11, 2014
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP,...
K132925 · NKB
Amendia, Inc.
Orthopedic · 146d
Cleared Feb 11, 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · KWS
Exactech, Inc.
Orthopedic · 32d
Cleared Feb 10, 2014
TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS
K133477 · HTY
Synchro Medical
Orthopedic · 90d
Cleared Feb 10, 2014
OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
K133583 · MAX
Interventional Spine, Inc.
Orthopedic · 81d
Cleared Feb 10, 2014
C-PLUS
K133623 · ODP
Pioneer Surgical Technology, Inc.
Orthopedic · 76d
Cleared Feb 07, 2014
TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION...
K131966 · LXC
Twin Star Medical, Inc.
Orthopedic · 224d
Cleared Feb 07, 2014
NB3D BONE VOID FILLER
K132050 · MQV
Pioneer Surgical Technology, Inc.
Orthopedic · 220d
Cleared Feb 07, 2014
RING-LOK MODULAR BIPOLAR SYSTEM
K132539 · KWY
Implants International, Ltd.
Orthopedic · 178d
Cleared Feb 07, 2014
DUOCENTRIC REVERSED SHOULDER PROSTHESIS
K133462 · KWS
Aston Medical
Orthopedic · 87d