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
13009–13032 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 13, 2001
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
K003911 · KWP
Terray Corp.
Orthopedic · 84d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Mar 13, 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Mar 09, 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM,...
K003816 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 09, 2001
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
K010367 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 30d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · HWC
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Mar 07, 2001
ALLOFIT ACETABULAR SYSTEM
K003758 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 91d
Cleared Mar 06, 2001
SHAVER ABLATOR
K002088 · HRX
Linvatec Corp.
Orthopedic · 238d
Cleared Mar 01, 2001
TI-REPLICA HIP STEM
K003875 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Mar 01, 2001
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL...
K003893 · HRX
Oratec Interventions, Inc.
Orthopedic · 73d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 82d
Cleared Feb 23, 2001
FREEDLAND TENSION SYSTEM
K003648 · MBI
Etzem Technologies, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
TRITON HIP SYSTEM
K003649 · LWJ
Hayes Medical, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 22, 2001
MTP RESESURFACING JOINT-SMALL/9301-01
K003629 · KWD
Terray Corp.
Orthopedic · 90d
Cleared Feb 20, 2001
PLGA PIN, MODEL...
K003659 · HTY
Bionx Implants, Inc.
Orthopedic · 84d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700 · HWC
Synthes (Usa)
Orthopedic · 81d
Cleared Feb 15, 2001
ENHANCED POLYETHYLENE KNEE PROSTHESES
K001147 · JWH
Howmedica Osteonics Corp.
Orthopedic · 311d
Cleared Feb 15, 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406 · MAI
Mitek Products
Orthopedic · 192d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572 · HRX
Smith & Nephew, Inc.
Orthopedic · 87d
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599 · HWC
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 15, 2001
PERFECTA AND EXTEND
K004032 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 49d
Cleared Feb 15, 2001
TRI-FIT FEMORAL STEM
K010243 · LWJ
Corin USA
Orthopedic · 21d
Cleared Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d