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
12673–12696 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 27, 2001
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR...
K013991 · JWH
Zimmer, Inc.
Orthopedic · 23d
Cleared Dec 27, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 16d
Cleared Dec 21, 2001
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · HTO
Synthes (Usa)
Orthopedic · 59d
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · HRS
Biomet, Inc.
Orthopedic · 251d
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897 · MQV
Synthes (Usa)
Orthopedic · 185d
Cleared Dec 20, 2001
SIGN IM NAIL
K013132 · HSB
Surgical Implant Generation Network...
Orthopedic · 92d
Cleared Dec 20, 2001
RT-PLUS KNEE ADDITIONAL COMPONENTS
K013340 · KRO
Plus Orthopedics
Orthopedic · 72d
Cleared Dec 20, 2001
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
K013424 · HTY
Hand Innovations, Inc.
Orthopedic · 66d
Cleared Dec 20, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · LPH
Howmedica Osteonics Corp.
Orthopedic · 62d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Dec 19, 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
K013449 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · MBI
Linvatec Corp.
Orthopedic · 55d
Cleared Dec 19, 2001
POLARUS CAP SCREW
K013616 · HSB
Acu Med, Inc.
Orthopedic · 44d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · KWP
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Dec 19, 2001
CODMAN SLIM-LOC SYSTEM
K013877 · KWQ
Codman & Shurtleff, Inc.
Orthopedic · 26d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Dec 19, 2001
GENERATION 4 BONE CEMENT
K993836 · LOD
Biomet, Inc.
Orthopedic · 768d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Dec 17, 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d
Cleared Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
K013534 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 55d
Cleared Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
K013786 · HWC
Doctor'S Research Group, Inc.
Orthopedic · 33d
Cleared Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
K013903 · HWC
Triad Medical, Inc.
Orthopedic · 21d
Cleared Dec 13, 2001
SPINE SCOPE, MODEL 2180
K011454 · HRX
Clarus Medical, LLC
Orthopedic · 216d