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
13153–13176 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 04, 2000
BROOKER TIBIA NAILS
K002057 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 04, 2000
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
K002484 · JDX
Electro Medical Systems SA
Orthopedic · 51d
Cleared Oct 04, 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared Oct 02, 2000
TORNIER TOTAL ELBOW PROSTHESIS
K000003 · JDC
Tornier
Orthopedic · 273d
Cleared Oct 02, 2000
ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437 · HRX
Endius, Inc.
Orthopedic · 54d
Cleared Sep 29, 2000
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS...
K002710 · HRS
Synthes (Usa)
Orthopedic · 29d
Cleared Sep 28, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K002796 · LWJ
Stelkast Company
Orthopedic · 21d
Cleared Sep 27, 2000
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
K001984 · JDG
Stelkast Company
Orthopedic · 90d
Cleared Sep 27, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 51d
Cleared Sep 22, 2000
SYNTHES MODULAR FOOT SYSTEM
K001941 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · HWC
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 19, 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 88d
Cleared Sep 19, 2000
ULTRASORB SUTURE ANCHOR
K002413 · MAI
Li Medical Technologies, Inc.
Orthopedic · 43d
Cleared Sep 19, 2000
ASCENT KNEE SYSTEM
K002678 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 19, 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · JWH
Biomet, Inc.
Orthopedic · 18d
Cleared Sep 15, 2000
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101,...
K000515 · MQV
Interpore Cross Intl.
Orthopedic · 212d
Cleared Sep 15, 2000
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K002371 · KWQ
Spineology, Inc.
Orthopedic · 50d
Cleared Sep 14, 2000
ACCOLADE C FEMORAL COMPONENT
K002320 · LZO
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Sep 12, 2000
USS VAS
K002517 · KWP
Synthes (Usa)
Orthopedic · 28d
Cleared Sep 12, 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND...
K002607 · KWP
Depuyacromed
Orthopedic · 21d
Cleared Sep 11, 2000
FMS SOLO
K002040 · HRX
Future Medical Systems, Inc.
Orthopedic · 68d
Cleared Sep 01, 2000
FENNING HIP STEM
K002441 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 23d
Cleared Aug 31, 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · JDQ
Pioneer Surgical Technology
Orthopedic · 87d