FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
12985–13008 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Nov 01, 2000
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
K002362 · MQV
Synthes (Usa)
Orthopedic · 90d
Cleared Oct 31, 2000
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
K002361 · HRS
Synthes (Usa)
Orthopedic · 89d
Cleared Oct 30, 2000
WUJIN #3 TIBIAL NAIL
K002325 · JDS
Biologically Oriented Prostheses
Orthopedic · 90d
Cleared Oct 30, 2000
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
K002356 · KRR
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 30, 2000
SYNTHES USS (10.0MM SIDE OPENING SCREWS)
K003061 · KWQ
Synthes
Orthopedic · 28d
Cleared Oct 27, 2000
MITEK CUFFTACK
K003076 · MAI
Mitek Products
Orthopedic · 24d
Cleared Oct 25, 2000
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
K002335 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · HRX
Radionics, Inc.
Orthopedic · 137d
Cleared Oct 23, 2000
BROOKER FEMORAL NAILS
K002278 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 23, 2000
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 19, 2000
GLOBAL SPINAL FIXATION SYSTEM
K001668 · MNH
D.K.M. Co., Ltd.
Orthopedic · 141d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121 · MNI
Synthes (Usa)
Orthopedic · 316d
Cleared Oct 16, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · KWP
Encore Orthopedics, Inc.
Orthopedic · 24d
Cleared Oct 13, 2000
TC-PLUS SOLUTION KNEE
K000666 · JWH
Plus Orthopedics
Orthopedic · 228d
Cleared Oct 13, 2000
XIA SPINE SYSTEM
K002858 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d