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
11521–11544 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 10, 2004
MODIFICATION TO SMARTPIN
K041288 · HTY
Linvatec Biomaterials, Inc.
Orthopedic · 28d
Cleared Jun 07, 2004
FEMORAL HOOK
K041261 · MBI
Arthrotek, Inc.
Orthopedic · 27d
Cleared Jun 04, 2004
VERSA-DIAL HUMERAL HEAD
K040610 · KWS
Biomet Manufacturing, Inc.
Orthopedic · 88d
Cleared Jun 04, 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · KWI
Biomet, Inc.
Orthopedic · 88d
Cleared Jun 04, 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · MEH
Exactech, Inc.
Orthopedic · 87d
Cleared Jun 03, 2004
PROCYON SPINAL SYSTEM
K033512 · MNH
Nas Medical Technologies, Inc.
Orthopedic · 210d
Cleared Jun 02, 2004
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE...
K033489 · MBH
Biomet, Inc.
Orthopedic · 211d
Cleared Jun 02, 2004
SWIFT ANTERIOR CERVICAL PLATE SYSTEM
K040655 · KWQ
Depuy Spine, Inc.
Orthopedic · 82d
Cleared Jun 02, 2004
SUMMIT OCT SPINAL SYSTEM
K041203 · MNI
Depuy Spine, Inc.
Orthopedic · 26d
Cleared Jun 01, 2004
NUCLEOTOME PROBE SET, MODEL 21200
K040919 · HRX
Clarus Medical, LLC
Orthopedic · 54d
Cleared May 28, 2004
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
K032522 · JWH
Exactech, Inc.
Orthopedic · 287d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K033971 · MBH
Howmedica Osteonics Corp.
Orthopedic · 158d
Cleared May 28, 2004
LITTLE GRAFTER SCREW
K040265 · HWC
Biocomposites, Ltd.
Orthopedic · 113d
Cleared May 28, 2004
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044...
K040544 · LPH
Depuy, Inc.
Orthopedic · 87d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
K040964 · JWH
Howmedica Osteonics Corp.
Orthopedic · 44d
Cleared May 28, 2004
PROFEMUR TAPERED HIP STEM
K041114 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared May 28, 2004
GII QUICKANCHOR PLUS
K041115 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 29d
Cleared May 28, 2004
SUPER QUICKANCHOR PLUS
K041116 · JDR
Depuy Mitek
Orthopedic · 29d
Cleared May 28, 2004
PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730
K041117 · JDR
Depuy Mitek
Orthopedic · 29d
Cleared May 28, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041118 · MNI
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared May 28, 2004
MODIFICATION TO BONE GRAFT WASHER
K041217 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared May 27, 2004
SPINAL CONCEPTS INC. CODA
K033663 · MQP
Spinal Concepts, Inc.
Orthopedic · 188d
Cleared May 27, 2004
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
K041160 · KRR
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared May 25, 2004
REFOBACIN -PALACOS G
K031673 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 361d