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
12433–12456 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · HWC
Arthrex, Inc.
Orthopedic · 85d
Cleared Apr 02, 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL...
K020221 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 70d
Cleared Mar 29, 2002
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K014302 · MNH
Pisharodi Surgicals, Inc.
Orthopedic · 88d
Cleared Mar 29, 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
K014305 · HTY
Arthrotek, Inc.
Orthopedic · 88d
Cleared Mar 29, 2002
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Mar 29, 2002
GAMMA 3 LAG SCREW
K020677 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Mar 27, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
K014304 · HWC
Triage Medical, Inc.
Orthopedic · 86d
Cleared Mar 27, 2002
UNIVERSAL BONE PLATE III SYSTEM (UBP III)
K020611 · HRS
Spinal Concepts, Inc.
Orthopedic · 30d
Cleared Mar 26, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL...
K014243 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · HWC
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Mar 22, 2002
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K020580 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 21, 2002
ODI TALON INTRAMEDULLARY HIP NAIL
K014189 · JDS
Orthopedic Designs, Inc.
Orthopedic · 90d
Cleared Mar 21, 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared Mar 21, 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · MQP
Depuyacromed
Orthopedic · 30d
Cleared Mar 18, 2002
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
K014154 · HWC
Vilex, Inc.
Orthopedic · 90d
Cleared Mar 18, 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155 · HRS
Arthrex, Inc.
Orthopedic · 89d
Cleared Mar 18, 2002
CERASORB ORTHO
K014156 · MQV
Curasan AG
Orthopedic · 89d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012778 · JWH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012787 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE...
K012788 · KWS
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
COAPT SYSTMES ENDOTINE DEVICE
K014153 · HWC
Coapt Systems, Inc.
Orthopedic · 87d
Cleared Mar 15, 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Mar 15, 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K020097 · JDW
Stryker Endoscopy
Orthopedic · 64d
Cleared Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572 · HWC
Mitek Products
Orthopedic · 136d