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
12937–12960 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 29, 2000
BIOMET EXTERNAL WRIST PLATE
K003240 · LXT
Biomet, Inc.
Orthopedic · 73d
Cleared Dec 28, 2000
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 76d
Cleared Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 75d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 301d
Cleared Dec 20, 2000
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K003728 · KWS
Tornier
Orthopedic · 16d
Cleared Dec 18, 2000
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
K002923 · LXT
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 15, 2000
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · KWP
Depuyacromed
Orthopedic · 105d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747 · LPH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Dec 15, 2000
TITAN TIBIAL NAIL
K003018 · HSB
Howmedica Osteonics Corp.
Orthopedic · 79d
Cleared Dec 15, 2000
TRANSFX ANGLED RODS
K003205 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared Dec 15, 2000
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
K003211 · LXT
Howmedica Osteonics Corp.
Orthopedic · 63d
Cleared Dec 15, 2000
M2A 32MM TAPER SYSTEM
K003363 · KWY
Biomet, Inc.
Orthopedic · 49d
Cleared Dec 15, 2000
PROTRACT PRESS FIT HIP STEM
K003447 · LPH
Stelkast Company
Orthopedic · 39d
Cleared Dec 15, 2000
ACE AIM TTC FUSION NAIL
K003797 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 7d
Cleared Dec 14, 2000
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K994337 · MQV
Orthovita Co.
Orthopedic · 357d
Cleared Dec 13, 2000
ORTHOMATRIX, INC. CERCLAGE SYSTEM
K001254 · JDQ
Orthomatrix, Inc.
Orthopedic · 238d
Cleared Dec 13, 2000
PRO-FEMUR R
K003016 · LWJ
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Dec 13, 2000
COPELAND RESURFACING HEADS
K003044 · HSD
Biomet, Inc.
Orthopedic · 75d
Cleared Dec 13, 2000
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K003523 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 11, 2000
VERSABOND BONE CEMENT
K001160 · LOD
Smith & Nephew, Inc.
Orthopedic · 245d
Cleared Dec 11, 2000
TRIDENT ALL POLY CUP
K001956 · JDI
Howmedica Osteonics Corp.
Orthopedic · 167d
Cleared Dec 11, 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960 · LPH
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · MEH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 11, 2000
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
K994146 · LWJ
Plus Orthopedics
Orthopedic · 369d