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
17209–17232 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 23, 1985
PROFILE FEMORAL HIP
K850055 · KWA
Depuy, Inc.
Orthopedic · 105d
Cleared Apr 22, 1985
T-SCREW
K851214 · HWC
Northeast Iowa Podiatry
Orthopedic · 27d
Cleared Apr 19, 1985
BIOMETRIC TOTAL HIP SYSTEM
K844787 · JDI
Biomedics
Orthopedic · 130d
Cleared Apr 19, 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · KWL
Biomet, Inc.
Orthopedic · 113d
Cleared Apr 19, 1985
LETOURNEL ACETABULAR PLATE
K850401 · HRS
Pfizer, Inc.
Orthopedic · 77d
Cleared Apr 19, 1985
MEC INTRAMEDULLARY ROD
K850441 · HSB
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
MEC BROAD BONE PLATE
K850442 · HRS
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
MEC BUTRESS PLATE
K850444 · HRS
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
INTERMEDICS BONE SCREW
K850770 · HWC
Intermedics Orthopedics
Orthopedic · 53d
Cleared Apr 17, 1985
H-H TENDEON IMPLANT
K843013
Holter-Hausner Intl.
Orthopedic · 260d
Cleared Apr 15, 1985
HENNING MENISCAL SUTURE KIT
K843942 · LXH
Stryker Corp.
Orthopedic · 188d
Cleared Apr 04, 1985
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K844214 · LXC
Stryker Corp.
Orthopedic · 155d
Cleared Mar 21, 1985
ACUFEX ARTHROSCOPIC SHAVER
K844130 · HSZ
Acufex Microsurgical, Inc.
Orthopedic · 149d
Cleared Mar 18, 1985
WEILL CEMENTLESS THREADED ACETABULAR CUP
K844943 · KWA
Advanced Biosearch Assn.
Orthopedic · 88d
Cleared Mar 12, 1985
MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
K844488 · KWL
Mecron Medical Products, Inc.
Orthopedic · 113d
Cleared Mar 12, 1985
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
K844817 · JDI
Osteonics Corp.
Orthopedic · 91d
Cleared Mar 11, 1985
EZ 505
K844162 · KIJ
Aeg Power Tool Corp.
Orthopedic · 138d
Cleared Mar 11, 1985
EZ 502
K844163 · KIJ
Aeg Power Tool Corp.
Orthopedic · 138d
Cleared Mar 05, 1985
MAYO ELBOW II
K843778
Zimmer, Inc.
Orthopedic · 161d
Cleared Mar 05, 1985
THREADED TITANIUM METAL BACKED ACETABULAR CUP
K844906 · LZO
Depuy, Inc.
Orthopedic · 78d
Cleared Mar 05, 1985
CFE ACETABULAR CUP
K844941 · JDI
Biomet, Inc.
Orthopedic · 75d
Cleared Feb 21, 1985
BROOKER ACETABULAR CUP
K845005 · JDI
Biomet, Inc.
Orthopedic · 57d
Cleared Feb 19, 1985
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
K844482 · JDL
Advanced Biosearch Assn.
Orthopedic · 92d
Cleared Feb 19, 1985
MECRON MRC-HEADLESS FEMORAL COMPONENT
K844486 · KWL
Mecron Medical Products, Inc.
Orthopedic · 92d