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
13489–13512 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 30, 1999
B2C, ESPACE REVISION CUP SYSTEM
K990523 · LPH
Turnkey Intergration USA, Inc.
Orthopedic · 70d
Cleared Apr 29, 1999
BUECHEL-PAPPAS MODULAR SALVAGE STEM
K982418 · MJT
Endotec, Inc.
Orthopedic · 290d
Cleared Apr 29, 1999
ROTORBLADE
K983435 · MAI
Li Medical Technologies, Inc.
Orthopedic · 212d
Cleared Apr 29, 1999
ENDOPEARL
K984171 · MAI
Linvatec Corp.
Orthopedic · 160d
Cleared Apr 29, 1999
EBI OMEGA 21 SYSTEM
K990303 · KWP
Electro-Biology, Inc.
Orthopedic · 87d
Cleared Apr 29, 1999
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K990596 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 64d
Cleared Apr 29, 1999
BOLD SCREW
K990622 · HWC
New Deal, S.A.
Orthopedic · 63d
Cleared Apr 29, 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · HWC
Aap Implantate AG
Orthopedic · 51d
Cleared Apr 29, 1999
STAYFUSE
K990804 · HWC
Pioneer Surgical Technology
Orthopedic · 50d
Cleared Apr 29, 1999
PROVIDENCE CUP SYSTEM
K990821 · JDI
Biopro, Inc.
Orthopedic · 49d
Cleared Apr 29, 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K991092 · KWQ
Electro-Biology, Inc.
Orthopedic · 28d
Cleared Apr 29, 1999
SOFT TISSUE SUTURE WASHER
K991135 · HTN
Depuy, Inc.
Orthopedic · 24d
Cleared Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED...
K991151 · HWC
Vilex, Inc.
Orthopedic · 20d
Cleared Apr 26, 1999
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX,...
K991197 · HWC
Vilex, Inc.
Orthopedic · 19d
Cleared Apr 23, 1999
EBI VUECATH ENDOSCOPIC SYSTEN
K990459 · HRX
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Apr 14, 1999
HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
K990361 · MAI
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 14, 1999
MODIFICATION OF: EBI SPINELINK SYSTEM
K990999 · MAI
Electro-Biology, Inc.
Orthopedic · 20d
Cleared Apr 13, 1999
MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
K990845 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 29d
Cleared Apr 08, 1999
OMEGA II MODULAR TOTAL HIP SYSTEM
K984227 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 134d
Cleared Apr 01, 1999
OMNI-FIX, NAIL SYSTEM
K990307 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 59d
Cleared Apr 01, 1999
PERRY HUMERAL NAIL
K990322 · HSB
Pioneer Surgical Technology
Orthopedic · 58d
Cleared Mar 31, 1999
ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
K990436 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 48d
Cleared Mar 30, 1999
TITANIUM VERSALOK
K990708 · KWP
Wrightmedicaltechnologyinc
Orthopedic · 26d
Cleared Mar 30, 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745 · MNI
Synthes Spine
Orthopedic · 22d