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
12865–12888 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 18, 2001
1.5MM BONE FIXATION KIT
K012000 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
SMARTSCREW
K012001 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
TRIDENT ALL POLY CUP
K012026 · JDI
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jul 16, 2001
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
K011076 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 98d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Jul 13, 2001
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
K010051 · JDR
Xiros Plc
Orthopedic · 186d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910 · HWC
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · HSD
Tornier
Orthopedic · 22d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · LXT
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · MQV
Biocomposites, Ltd.
Orthopedic · 203d
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823 · KWP
Ortho Tec, LLC
Orthopedic · 212d
Cleared Jul 11, 2001
SIGN IM NAIL
K011129 · HSB
Sign, Inc.
Orthopedic · 89d
Cleared Jul 10, 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138 · HRY
Biomet, Inc.
Orthopedic · 88d
Cleared Jul 06, 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · HWC
Osteomed Corp.
Orthopedic · 97d
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · HRS
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 02, 2001
M2A ACETABULAR SYSTEM
K011110 · KWA
Biomet, Inc.
Orthopedic · 82d
Cleared Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · HWC
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 29, 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711 · KTT
Ebi, L.P.
Orthopedic · 25d
Cleared Jun 28, 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Jun 28, 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE...
K011083 · HRX
Arthrocare Corp.
Orthopedic · 79d
Cleared Jun 28, 2001
SCORPIO CR SUPERFLEX TIBIAL INSERT
K011643 · JWH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jun 27, 2001
ORTHOGENESIS LPS SYSTEM
K003182 · JWH
Depuy, Inc.
Orthopedic · 259d