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
13081–13104 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Dec 08, 2000
OPUS ROD FIXATION SYSTEM
K003490 · MNH
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Dec 05, 2000
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
K002775 · HRS
Hand Innovations, Inc.
Orthopedic · 90d
Cleared Dec 05, 2000
FIXION INTERLOCKING NAIL (FIXION IL NAIL)
K002783 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Dec 04, 2000
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
K002755 · LRN
T. Korossurgical Instruments Corp.
Orthopedic · 90d
Cleared Dec 04, 2000
ACETABULAR PLATES
K002941 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 74d
Cleared Dec 04, 2000
U1 HIP SYSTEM
K994078 · LPH
United Orthopedic Corp.
Orthopedic · 368d
Cleared Dec 01, 2000
DEPUY C-STEM SYSTEM
K003421 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Nov 30, 2000
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
K002740 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 30, 2000
V-40/C-TAPER ADAPTER SLEEVE
K003379 · LZO
Howmedica Osteonics Corp.
Orthopedic · 30d