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
14473–14496 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 10, 1996
IM C-MENT ACETABULAR CAP
K955137 · JDI
Implant Ideas, LLC
Orthopedic · 332d
Cleared Oct 10, 1996
KARL STORZ MAGNIFYING ARTHROSOCPES
K961228 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 195d
Cleared Oct 10, 1996
EXTREMITY BONE SCREW
K963118 · HWC
Acu Med, Inc.
Orthopedic · 59d
Cleared Oct 10, 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398 · HWC
Howmedica Corp.
Orthopedic · 42d
Cleared Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K955877 · LZO
Zimmer, Inc.
Orthopedic · 287d
Cleared Oct 08, 1996
DELTA HIP PROSTHESIS
K961378 · LWJ
Zimmer, Inc.
Orthopedic · 181d
Cleared Oct 08, 1996
APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
K961590 · HRX
Linvatec Corp.
Orthopedic · 167d
Cleared Oct 03, 1996
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
K960425 · JDI
Endotec, Inc.
Orthopedic · 248d
Cleared Oct 03, 1996
MITEK THREADED ANCHOR (MODIFICATION)
K961094 · MBI
Mitek Products
Orthopedic · 203d
Cleared Oct 03, 1996
TWIST-OFF SCREW
K962233 · HWC
Landos, Inc.
Orthopedic · 114d
Cleared Oct 03, 1996
HORIZON HIP SYSTEM
K962769 · LPH
Biologically Oriented Prostheses
Orthopedic · 79d
Cleared Oct 02, 1996
ULTIUM SPINAL PLATING SYSTEM
K962784 · MNH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 77d
Cleared Oct 02, 1996
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K963200 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 48d
Cleared Oct 02, 1996
ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963217 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 47d
Cleared Oct 01, 1996
COTREL-DUBOUSSET (CD) SPINAL
K955807 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 284d
Cleared Oct 01, 1996
PRESS-FIT FLARED SHELL
K960633 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 230d
Cleared Oct 01, 1996
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K961304 · JDI
Exactech, Inc.
Orthopedic · 180d
Cleared Oct 01, 1996
MLI MODULAR STAPLE
K962705 · JDR
Medicinelodge, Inc.
Orthopedic · 81d
Cleared Oct 01, 1996
MITEK MICRO ANCHOR
K962793 · JDR
Mitek Products
Orthopedic · 76d
Cleared Oct 01, 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823 · HWC
Synthes (Usa)
Orthopedic · 74d
Cleared Oct 01, 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923 · LPH
Depuy, Inc.
Orthopedic · 64d
Cleared Oct 01, 1996
TIBIAL INSERT
K963028 · JWH
Encore Orthopedics, Inc.
Orthopedic · 57d
Cleared Oct 01, 1996
TBD
K963077 · HSB
Acu Med, Inc.
Orthopedic · 54d
Cleared Oct 01, 1996
INTERMOORE FRACTURE HIP STEM (MODIFY)
K963155 · LWJ
Intermedics Orthopedics
Orthopedic · 57d