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
12169–12192 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 13, 2002
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
K020703 · JWH
Howmedica Osteonics Corp.
Orthopedic · 254d
Cleared Nov 13, 2002
AMT POLYAXIAL PEDICLE SCREW
K022768 · MNI
Micron Precision Engineering, Inc.
Orthopedic · 84d
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · KWQ
Synthes (Usa)
Orthopedic · 83d
Cleared Nov 13, 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Nov 13, 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 13, 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498 · KWP
Blackstone Medical, Inc.
Orthopedic · 26d
Cleared Nov 13, 2002
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
K023562 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 21d
Cleared Nov 13, 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · JDI
Exactech, Inc.
Orthopedic · 14d
Cleared Nov 08, 2002
COLUMBUS TOTAL KNEE SYSTEM (CR)
K022672 · JWH
Aesculap, Inc.
Orthopedic · 88d
Cleared Nov 08, 2002
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 08, 2002
MODIFICATION TO VKS KNEE SYSTEM
K023416 · JWH
Plus Orthopedics
Orthopedic · 28d
Cleared Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
K023417 · JDR
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Nov 06, 2002
ARCPM 1050 RESIN-HIPS
K023357 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 05, 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · MQV
Biocomposites, Ltd.
Orthopedic · 172d
Cleared Nov 01, 2002
K-FIX
K022597 · HTY
New Deal, S.A.
Orthopedic · 88d
Cleared Oct 31, 2002
OSSTAPLE, MAXILLOFACIAL
K023486 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 31, 2002
OSSTAPLE, CRANIOFACIAL
K023488 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 30, 2002
NEWDEAL K WIRE
K022599 · HTY
New Deal, S.A.
Orthopedic · 86d
Cleared Oct 29, 2002
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
K022615 · JDK
Centerpulse Spine-Tech, Inc.
Orthopedic · 83d
Cleared Oct 25, 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · KWQ
Spinal Concepts, Inc.
Orthopedic · 165d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS
K021661 · KWZ
Biomet Orthopedics, Inc.
Orthopedic · 158d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS II
K021728 · KWZ
Biomet, Inc.
Orthopedic · 154d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302 · MEH
Smith & Nephew, Inc.
Orthopedic · 22d