FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
9553–9576 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 26, 2008
SI JOINT FUSION SYSTEM
K080398 · OUR
SI-BONE, Inc.
Orthopedic · 287d
Cleared Nov 25, 2008
POGO SCREW
K080649 · HWC
Fxdevices
Orthopedic · 263d
Cleared Nov 25, 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
K082358 · JWH
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Nov 25, 2008
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
K082575 · MQV
Apatech , Ltd.
Orthopedic · 81d
Cleared Nov 25, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET...
K082844 · LZO
Encore Medical, L.P.
Orthopedic · 60d
Cleared Nov 25, 2008
ORTHOPEDIATRICS BONE SCREWS
K082949 · HWC
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Nov 24, 2008
PROGENIX PLUS
K082002 · MQV
Medtronic Sofamor Danek
Orthopedic · 133d
Cleared Nov 24, 2008
USS ILIOSACRAL, USS POLYAXIAL
K082572 · NKB
Synthes Spine
Orthopedic · 80d
Cleared Nov 24, 2008
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED...
K082807 · HRS
Synthes (Usa)
Orthopedic · 61d
Cleared Nov 21, 2008
ISOELASTICU
K081025 · KXE
Remi Sciences, Inc.
Orthopedic · 225d
Cleared Nov 21, 2008
TSRH SPINAL SYSTEM
K081080 · NKB
Medtronic Sofamor Danek
Orthopedic · 219d
Cleared Nov 20, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
K082991 · LZO
Aesculap Implant Systems, Inc.
Orthopedic · 44d
Cleared Nov 19, 2008
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
K081380 · KWQ
K2m, Inc.
Orthopedic · 187d
Cleared Nov 18, 2008
DEPUY SIGMA CR-F FEMORAL COMPONENT
K082500 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 81d
Cleared Nov 18, 2008
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650 · KTT
Synthes (Usa)
Orthopedic · 67d
Cleared Nov 14, 2008
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
K081673 · MAX
Ionics Medical Corp.
Orthopedic · 154d
Cleared Nov 14, 2008
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K081906 · KWP
Globus Medical, Inc.
Orthopedic · 134d
Cleared Nov 14, 2008
DEPUY SPINE LATERAL CAGE SYSTEM
K082128 · MAX
Depuy Spine
Orthopedic · 108d
Cleared Nov 14, 2008
GENEX
K082381 · MQV
Biocomposites, Ltd.
Orthopedic · 87d
Cleared Nov 14, 2008
VERTEX RECONSTRUCTION SYSTEM
K083071 · KWP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 13, 2008
BIOMET ANTERIOR LUMBAR PLATE
K082187 · KWQ
Ebi, L.P.
Orthopedic · 101d
Cleared Nov 13, 2008
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
K083028 · NKB
Nuvasive, Inc.
Orthopedic · 34d
Cleared Nov 10, 2008
HOLLYWOOD, PACIFICA, REDONDO, VENTURA
K082310 · MAX
Seaspine, Inc.
Orthopedic · 89d
Cleared Nov 10, 2008
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES
K082624 · HRS
Synthes (Usa)
Orthopedic · 62d