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
8233–8256 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 13, 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103784 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 107d
Cleared Apr 13, 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103795 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 107d
Cleared Apr 11, 2011
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072 · LPH
Howmedica Osteonics Corp.
Orthopedic · 357d
Cleared Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
K110101 · LZO
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 11, 2011
LATARJET CORTICAL SCREW SET
K110763 · HWC
T.A.G. Medical Products Corporation,...
Orthopedic · 24d
Cleared Apr 08, 2011
LP CAGE
K110067 · MAX
Medyssey Co, Ltd.
Orthopedic · 88d
Cleared Apr 07, 2011
ACCULIF CAGE
K110270 · MAX
Coalign Innovations, Inc.
Orthopedic · 66d
Cleared Apr 07, 2011
MOUNTAINEER OCT SPINAL SYSTEM
K110353 · KWP
Depuy Spine, Inc.
Orthopedic · 59d
Cleared Apr 05, 2011
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K103262 · MBI
Tornier, Inc.
Orthopedic · 152d
Cleared Apr 04, 2011
BRAINLAB KNEE
K102990 · OLO
Brainlab AG
Orthopedic · 178d
Cleared Apr 04, 2011
VAULT ALIF SYSTEM
K103369 · OVD
Spinal USA
Orthopedic · 138d
Cleared Apr 04, 2011
KNEEALIGN SYSTEM
K103829 · OLO
Orthalign, Inc.
Orthopedic · 95d
Cleared Apr 01, 2011
COMPRESSYN BAND
K101484 · JDQ
Dallen Medical
Orthopedic · 308d
Cleared Apr 01, 2011
EXPEDIUM SYSTEM, VIPER SYSTEM
K110216 · NKB
Depuy Spine, Inc.
Orthopedic · 66d
Cleared Apr 01, 2011
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Apr 01, 2011
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
K110542 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 36d
Cleared Apr 01, 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE /...
K110708 · PHX
Exactech, Inc.
Orthopedic · 18d
Cleared Mar 31, 2011
ARTHREX BIOCOMPOSITE SUTURETAK
K110660 · MAI
Arthrex, Inc.
Orthopedic · 24d
Cleared Mar 30, 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · OVD
Alphatec Spine, Inc.
Orthopedic · 218d
Cleared Mar 25, 2011
SYNTEC OS SPINAL FIXATION SYSTEM
K101971 · NKB
Syntec Scientific Corp.
Orthopedic · 255d
Cleared Mar 25, 2011
APEX PS KNEE SYSTEM
K102578 · JWH
Omni Life Science, Inc.
Orthopedic · 198d
Cleared Mar 25, 2011
LANX SPINAL SYSTEM
K103237 · NKB
Lanx, Inc.
Orthopedic · 143d
Cleared Mar 25, 2011
CAPTIVA SPINE FUSELOX CERVICAL CAGE
K110585 · ODP
Captiva Spine, Inc.
Orthopedic · 24d
Cleared Mar 24, 2011
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
K094035 · OQG
Stelkast Company
Orthopedic · 449d