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
13105–13128 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 30, 2000
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K003429 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Nov 28, 2000
OSTEONICS ALUMINA C-TAPER HEAD
K003391 · LZO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Nov 24, 2000
COD COMPRESSION OSTEOTOMY DEVICE
K002184 · HRS
Walter Abendschein, M.D.
Orthopedic · 128d
Cleared Nov 24, 2000
ONCOLOGY SALVAGE SYSTEM
K002757 · JDI
Biomet, Inc.
Orthopedic · 80d
Cleared Nov 24, 2000
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
K002764 · HRX
Hydrocision, Inc.
Orthopedic · 80d
Cleared Nov 24, 2000
METRX SYSTEM
K002931 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 65d
Cleared Nov 24, 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · MNH
Osteotech, Inc.
Orthopedic · 24d
Cleared Nov 24, 2000
ALUMINA V40 HEAD
K003413 · LZO
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 24, 2000
ISS OFFSET HEADS
K003428 · HSD
Biomet, Inc.
Orthopedic · 21d
Cleared Nov 22, 2000
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
K002683 · KWS
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Nov 20, 2000
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605 · JDW
Synthes (Usa)
Orthopedic · 90d
Cleared Nov 20, 2000
RADIAL HEAD IMPLANT
K002644 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 88d
Cleared Nov 15, 2000
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
K002575 · LWJ
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Nov 15, 2000
LITWIN CRUICATE ANCHOR
K002600 · MBI
Instrument Makar, Inc.
Orthopedic · 86d
Cleared Nov 13, 2000
AMT SPINAL SYSTEM
K002059 · KWP
Micron Precision Engineering, Inc.
Orthopedic · 130d
Cleared Nov 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · KRO
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 09, 2000
PRECIMED TRAUMA SYSTEM
K002486 · HRS
Patrick Berdoz
Orthopedic · 87d
Cleared Nov 07, 2000
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
K003181 · LPH
Implex Corp.
Orthopedic · 27d
Cleared Nov 06, 2000
PE.R.I. II KNEE FRACTURE SYSTEM
K003235 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Nov 06, 2000
BIOMET SCK KNEE SYSTEM
K003296 · JWH
Biomet, Inc.
Orthopedic · 17d
Cleared Nov 03, 2000
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
K001044 · MNH
Acme Spine, LLC
Orthopedic · 217d
Cleared Nov 03, 2000
BIOMET LATERAL TROCH PLATE
K003294 · JDW
Biomet, Inc.
Orthopedic · 14d
Cleared Nov 02, 2000
SIMPLICITY SPINAL SYSTEM
K002103 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 113d
Cleared Nov 02, 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · JDW
Biomet, Inc.
Orthopedic · 27d