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
13777–13800 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 10, 1998
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121 · KWP
Aesculap, Inc.
Orthopedic · 147d
Cleared Jun 10, 1998
ROGACHEFSKY DISTAL RADIUS PLATES
K981283 · HRS
Howmedica, Inc.
Orthopedic · 63d
Cleared Jun 08, 1998
IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
K981560 · JWH
Implex Corp.
Orthopedic · 38d
Cleared Jun 02, 1998
EXETER INTRAMEDULLARY BONE PLUG
K980843 · JDI
Howmedica, Inc.
Orthopedic · 90d
Cleared Jun 01, 1998
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K981230 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 59d
Cleared May 29, 1998
J-FX BIPOLAR HEAD
K980801 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 88d
Cleared May 29, 1998
PEDIATRIC PRC
K981113 · MNH
Acromed Corp.
Orthopedic · 63d
Cleared May 29, 1998
OSTEOLOCK ACETABULAR CUP
K981201 · LZO
Howmedica Corp.
Orthopedic · 57d
Cleared May 27, 1998
OSTEONICS ANTEVERTED NECK HA HIP STEMS
K980766 · MEH
Osteonics Corp.
Orthopedic · 89d
Cleared May 27, 1998
SIMAL CERVICAL STABILIZATION SYSTEM
K981008 · KWQ
Top Surgical Products GmbH
Orthopedic · 70d
Cleared May 22, 1998
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY...
K974245 · LXT
Depuy Ace Medical Co.
Orthopedic · 191d
Cleared May 22, 1998
CABLE SCREW WITH INTEGRAL CRIMP
K980690 · JDQ
Pioneer Surgical Technology
Orthopedic · 88d
Cleared May 22, 1998
FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM
K980713 · JWH
Howmedica Corp.
Orthopedic · 87d
Cleared May 22, 1998
IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS
K980781 · JWH
Implex Corp.
Orthopedic · 81d
Cleared May 22, 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K980788 · JDW
Alphatec Mfg., Inc.
Orthopedic · 81d
Cleared May 22, 1998
APR -T REVISION HIP STEM
K981211 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 50d
Cleared May 20, 1998
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665 · HRY
Biomet, Inc.
Orthopedic · 89d
Cleared May 20, 1998
DUAL LOCK HIP STEM
K980794 · JDI
Depuy, Inc.
Orthopedic · 79d
Cleared May 20, 1998
RCI FIXATION SCREWS
K980841 · HWC
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared May 20, 1998
TITANIUM SPINAL ROD SYSTEM
K980862 · MNH
United States Surgical, A Division of...
Orthopedic · 76d
Cleared May 20, 1998
OMEGA HA COATED TOTAL HIP SYSTEM
K980981 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 64d
Cleared May 20, 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156 · HRX
Smith & Nephew, Inc.
Orthopedic · 50d
Cleared May 20, 1998
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
K981423 · JEC
Autogenesis, Inc.
Orthopedic · 30d
Cleared May 20, 1998
OSTEONICS LONG ARM CONTAINMENT RING
K981452 · KWP
Osteonics Corp.
Orthopedic · 28d