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
14497–14520 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 23, 1996
APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA
K960535 · JWH
Intermedics Orthopedics
Orthopedic · 76d
Cleared Apr 23, 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · HWE
Exactech, Inc.
Orthopedic · 61d
Cleared Apr 18, 1996
LM BONE ANCHOR
K960439 · MBI
Li Medical Technologies, Inc.
Orthopedic · 78d
Cleared Apr 18, 1996
WEBB-MORLEY SPINE SYSTEM
K960451 · MNH
Buckman Co., Inc.
Orthopedic · 79d
Cleared Apr 18, 1996
FASTAK SUTURE ANCHOR
K960516 · MBI
Arthrex, Inc.
Orthopedic · 73d
Cleared Apr 18, 1996
MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
K960626 · JDI
Intermedics Orthopedics
Orthopedic · 65d
Cleared Apr 17, 1996
LM ANCHOR
K960448 · MBI
Li Medical Technologies, Inc.
Orthopedic · 78d
Cleared Apr 15, 1996
FOUNDATION GLENOID COMPONENT
K960906 · KWS
Encore Orthopedics, Inc.
Orthopedic · 41d
Cleared Apr 10, 1996
OMEGA+ COMPRESSION SCREW SYSTEM
K955306 · KTT
Howmedica Corp.
Orthopedic · 142d
Cleared Apr 10, 1996
ARTHOSCOPE
K960805 · HRX
United States Surgical, A Division of...
Orthopedic · 42d
Cleared Apr 10, 1996
LACTOSORB TRAUMA PLATING SYSTEM
K960988 · HRS
Poly-Medics,Inc.
Orthopedic · 34d
Cleared Apr 09, 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955944 · KWS
Osteonics Corp.
Orthopedic · 133d
Cleared Apr 09, 1996
K-WIRE
K960482 · HTY
American Medical Specialties, Inc.
Orthopedic · 67d
Cleared Apr 09, 1996
STEINMAN PIN
K960483 · HTY
American Medical Specialties, Inc.
Orthopedic · 67d
Cleared Apr 08, 1996
COFIED MODULAR SHOULDER SYSTEM
K955767 · KWS
Smith & Nephew Richards, Inc.
Orthopedic · 109d
Cleared Apr 05, 1996
IMPLEX CERAMIC HEAD
K955117 · LZO
Implex Corp.
Orthopedic · 148d
Cleared Apr 04, 1996
OSTEONICS OFFSET HIP STEMS
K954598 · JDI
Osteonics Corp.
Orthopedic · 184d
Cleared Apr 04, 1996
TITANIUM UNIVERSAL CLAMP
K960269 · LXT
Synthes (Usa)
Orthopedic · 77d
Cleared Apr 03, 1996
BONUTTI ANCHOR
K934183 · MBI
Apogee Medical Products, Inc.
Orthopedic · 951d
Cleared Apr 02, 1996
SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE
K960046 · HRX
Surgical Dynamics, Inc.
Orthopedic · 91d
Cleared Apr 01, 1996
CONSENSUS ALL POLY TIBIA
K952943 · JWH
U.S. Medical Products, Inc.
Orthopedic · 280d
Cleared Apr 01, 1996
ACE HUMERUS & RADIUS PLATES
K955472 · HRS
Ace Medical Co.
Orthopedic · 123d
Cleared Apr 01, 1996
CONSENSUS ACETABULAR SHELL, ALL UHMWPE
K960302 · JDI
U.S. Medical Products, Inc.
Orthopedic · 70d
Cleared Mar 27, 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 126d