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
12697–12720 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · MBI
Arthocare Corporation
Orthopedic · 65d
Cleared Dec 13, 2001
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739 · LXT
Ebi, L.P.
Orthopedic · 30d
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 15d
Cleared Dec 11, 2001
MJS POSTERIOR STABILIZED KNEE SYSTEM
K012762 · HRY
Osteoimplant Technology, Inc.
Orthopedic · 116d
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · HWC
United States Surgical, A Division of...
Orthopedic · 18d
Cleared Dec 10, 2001
REUNITE FUSION SCREW
K011451 · HWC
Biomet, Inc.
Orthopedic · 213d
Cleared Dec 07, 2001
MOST OPTIONS SYSTEM
K013031 · KRO
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 07, 2001
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · KRO
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Dec 06, 2001
PLASMA SPRAYED SHOULDER
K003324 · KWS
Encore Orthopedics, Inc.
Orthopedic · 408d
Cleared Dec 05, 2001
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · KWY
Exactech, Inc.
Orthopedic · 70d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 05, 2001
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
K013676 · MEH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · MNH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 05, 2001
AUTOGENESIS AUTOMATOR, MODEL M1000
K013818 · JEC
Autogenesis, Inc.
Orthopedic · 19d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572 · HWC
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · HWC
Synthes (Usa)
Orthopedic · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · HWC
Synthes (Usa)
Orthopedic · 84d
Cleared Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 27d
Cleared Dec 03, 2001
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K013772 · LXT
Howmedica Osteonics
Orthopedic · 20d
Cleared Nov 29, 2001
RESECTION ABLATOR
K013117 · HRX
Linvatec Corp.
Orthopedic · 72d
Cleared Nov 27, 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · KWP
Ebi, L.P.
Orthopedic · 113d