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
14977–15000 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 27, 1995
10.5MM REPLICA HIP STEM
K951095 · LPH
Depuy, Inc.
Orthopedic · 50d
Cleared Apr 26, 1995
SELBY INSTRUMENTATION
K943775 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 267d
Cleared Apr 26, 1995
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
K943873 · LXH
Orthomet, Inc.
Orthopedic · 260d
Cleared Apr 26, 1995
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
K944792 · JDI
Zimmer, Inc.
Orthopedic · 210d
Cleared Apr 26, 1995
SELBY INSTRUMENTATION
K945064 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 194d
Cleared Apr 26, 1995
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 117d
Cleared Apr 25, 1995
CLARUS PHOENIX ENDOSCOPE
K940144 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 469d
Cleared Apr 25, 1995
CLARUS NEURO ENDOSCOPE (MODEL 2230)
K941188 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 407d
Cleared Apr 18, 1995
PROFORM POROUS ACETABULAR ASSEMBLY
K950827 · LPH
Stelkast Company
Orthopedic · 54d
Cleared Apr 18, 1995
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K951301 · LPH
Depuy, Inc.
Orthopedic · 27d
Cleared Apr 14, 1995
ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
K941709 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 373d
Cleared Apr 14, 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · HWC
Arthrex, Inc.
Orthopedic · 161d
Cleared Apr 14, 1995
SPETZLER PIN
K945639 · HTY
Howmedica Corp.
Orthopedic · 149d
Cleared Apr 14, 1995
ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
K951000 · LPH
Joint Medical Products Corp.
Orthopedic · 42d
Cleared Apr 13, 1995
BONE PLATE SYSTEM
K942359 · HRS
Acu Med, Inc.
Orthopedic · 331d
Cleared Apr 13, 1995
SPINAL MARKER
K944188 · LXH
Leibinger L.P.
Orthopedic · 230d
Cleared Apr 13, 1995
MODUILAR UNIPOLAR
K950998 · KXA
Intermedics Orthopedics
Orthopedic · 41d
Cleared Apr 10, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K944836 · MEH
Osteonics Corp.
Orthopedic · 192d
Cleared Apr 10, 1995
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
K945793 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 136d
Cleared Apr 10, 1995
OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
K946234 · MEH
Osteonics Corp.
Orthopedic · 109d
Cleared Apr 10, 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105 · HRS
Howmedica Corp.
Orthopedic · 89d
Cleared Apr 10, 1995
LUHR(R) TITANIUM BURR HOLE COVERS
K950115 · HRS
Howmedica, Inc.
Orthopedic · 89d
Cleared Apr 07, 1995
PRIME CEMENTED HIP SYSTEM
K940328 · JDI
Orthopaedic Innovations, Inc.
Orthopedic · 438d
Cleared Apr 05, 1995
CONSENSUS(TM) PATELLA REAMER
K946197 · HWE
U.S. Medical Products, Inc.
Orthopedic · 106d